Mild Cognitive ImpairmentNCT06467253
Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI)
A study testing 1. rTMS + CS and 3. tDCS + CS in people with Mild Cognitive Impairment, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
Trial summary
This is a comparative, double-blind, randomized controlled clinical trial for people with Amnestic Mild Cognitive Impairment. The investigators will compare the effects of two non-invasive neuromodulation techniques (Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation) combined… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- 1. rTMS + CS and 3. tDCS + CS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteMexico
- Study dates
- 1 Jun 2023to 15 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being vaccinated against the SARS-COV2 virus.
- Speak Spanish fluently.
- Level of schooling greater than or equal to 6 years.
- Amnestic mild cognitive impairment established by clinical examination performed by the treating physician (MoCA score: 19-25 points for probable aMCI) (based on the National Institute on Aging and Alzheimer's Association (NIA/AA) criteria, 2011).
- Adequate visual and auditory acuity to perform neuropsychological tests and cognitive rehabilitation.
- If receiving psychotropic drugs, having started the drugs at least 12 weeks before the start of the study, remaining at stable doses, or having suspended the drugs for at least 4 weeks before the study.
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- Be in good health without non-psychiatric medical diseases (uncontrolled systemic arterial hypertension, diabetes mellitus or dyslipidemia, infections, thyroid disease, vitamin deficiency) interfering with the study.
- Willingness to participate in a study scheduled for 8 weeks and that participants can go to the Instituto Nacional De Psiquiatría for treatments, as well as scheduled evaluations.
- An informant to respond to some of the assessment questionnaires throughout the study and who would stay with the participant for at least 10 h/week.
Who cannot join
- Any neurological disease that raises suspicion of cognitive failure other than Alzheimer's disease, such as Parkinson's, multi-infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of trauma craniocerebral with loss of alertness.
- Participants with a history of severe psychiatric disorders according to DSM-5 (bipolar disorder, schizophrenia, chronic depression) or with psychotic features, agitation, or behavioral problems in the last three months that could lead to difficulties in meeting the protocol.
- History of psychoactive substance abuse and current alcohol consumption with a pattern of abuse or dependence in the last two years.
- Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist).
- Participants with pacemakers, intracranial metal objects, or history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.
- Participation in the last 6 months in a clinical study that involved neuropsychological assessment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
Mexico City, 14370
Ruth Alcalá Lozano, Dr., 5541605065 ext. 5065, ruthalcala@inprf.gob.mx
About this study
Official title: Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI): Genetic Characterization, Proteins Associated With Neurogenesis, Clinical, Neuroimaging and Electrophysiological Markers
This is a comparative, double-blind, randomized controlled clinical trial for people with Amnestic Mild Cognitive Impairment. The investigators will compare the effects of two non-invasive neuromodulation techniques (Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation) combined with cognitive stimulation. These non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare non-invasive techniques with cognitive stimulation CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow the investigators to characterize the participants; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells and solubles factors of serum; 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex by means of structural magnetic resonance imaging and the default mode network by means of functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude and latency in order to generate a response-to-treatment biomarker with neuromodulators in Mild Cognitive Impairment (MCI) and changes in electroencephalogram.
Read the detailed description
Mild Cognitive Impairment can be described as an intermediate stage between intact cognition and dementia, this study has become a global priority due to alarming changes in the population pyramid that place the world population at a higher risk of developing dementia. The global prevalence of MCI is between 15-20% in people over 60 years old. In 2012, a prevalence of MCI of 3.2% was found in Mexico City, which encourages the researchers to study this phenomenon to achieve early detection and create interventions that could delay the onset of dementia and even prevent it. Symptomatology is distinguished by deficits in one or more cognitive domains through formal tests applied repeatedly; the individual can manifest symptoms directly by identifying as different from a previous state and/or being corroborated by an informant. The amnestic cognitive impairment (aMCI) occurs when the cognitive failure is limited only to the domain of episodic memory. Generally, there is a slight functional impairment for complex tasks, but the basic and instrumental activities of daily life must be preserved. Behavioral and psychological symptoms (BPSD) can occur. Apathy, anxiety, and depression present in patients with mild cognitive impairment may represent an increased risk of dementia and in many cases, can be the first symptoms to appear. The evaluation is essential because BPSD are often controllable with treatment and appears in up to 77% of patients with MCI.
Despite the need to stop the progression to dementia, a MCI treatment is currently nonspecific, focused on associated events, with pharmacological and non-pharmacological measures aimed to reduce cognitive and neuropsychiatric symptoms. Therapeutic methods that promote neuroplasticity, for instance, cognitive stimulation (CS) and non-invasive neuromodulatory techniques such as Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS), optimize performance by stimulating the neural network distributed around a dysfunctional circuit, interacting with brain plasticity, and inducing or increasing compensatory mechanisms. This phenomenon could add to the cognitive reserve and interfere with the temporal evolution of the symptoms. Thereby, the rTMS and tDCS have been suggested as a possible treatment in aMCI. These non-invasive alternatives (rTMS and tDCS) have shown efficacy as a treatment in other disorders, but evidence is required on the efficacy, tolerability, and viability of the application in patients with amnesic MCI as well as the time that the effect of its application remains, which creates the need of further studies with maintenance phases.
In this project, the researchers propose a clinical trial for participants with risk of developing dementia using rTMS and tDCS added to CS in an effectiveness comparison using strict placebo control methods which will only be used with rTMS and tDCS, not with CS. The non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare the techniques with CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow to characterize patients; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells isolated before and after treatment. In addition to the documentation of soluble factors secreted by olfactory epithelial neural progenitor cells, what is relevant to the knowledge of the influence of peripheral serum on microglia. This is crucial role in inflammation. The evaluations will be performed at different time points such as: Baseline (T0), after first phase of treatment (T1=15 sessions/week of tDCS+CS), after maintenance (T2=12 sessions/week of tDCS+CS), and follow-up phase (T3=1 year after treatment); 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex using structural magnetic resonance imaging and the default mode network using functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude to generate a response-to-treatment biomarker with neuromodulators in MCI and changes in electroencephalogram (EEG).
Among the current limitations on knowledge of this disease, many studies use biomarkers to predict MCI or progression to dementia, and although most biomarkers are reported to be valuable in this setting, few are compared with each other, so this is currently difficult to understand the relative importance of the different biomarkers when used together. For this reason, the present project could be a contribution in the short and long term to detect changes that may or may not be related to each other and generate multiple lines of research.
Population aging will continue to increase and therefore there will be a greater number of people with aMCI. Currently, there is no treatment that prevents the progression of aMCI to AD, so the trend is to make earlier interventions. aMCI is a condition of opportunity because the cognitive reserve of the patients has not been exhausted, so developing studies with innovative treatments and few side effects that can change the evolution over time is important. To that end, understanding the etiology of this progression and designig treatments that delay or definitively stop aMCI are of importance to preserve the functionality of individuals with this condition.
Clinical trials with rTMS and tDCS carried out in aMCI have already shown favorable results regarding episodic memory, semantic memory, and speed of information processing. This trial will be able to contribute to the already reported findings that allow to identify better therapeutic approaches that support the standardization of the application of neuromodulatory techniques. Besides, the possible additive effect of neuromodulatory techniques and CS is well known, but no studies are comparing between diferent interventions with each other. The genetic characterization will be obtained, an experimental biomarker of secretion proteins from olfactory epithelial neural progenitor cells together with the analysis of the neurogenic process occurring in the olfactory epithelium will be generated, an experimental biomarker of serum and the effects soluble factors contained in serum on microglia will be generated, neuroimaging and produce neurophysiological measures considered as possible neuroplasticity biomarkers (MEPs and EEG) associated with the response to non-pharmacological treatment will be recorded and evaluated if the parameters are related to clinical and cognitive characteristics. With this therapeutic approach where non-invasive neuromodulatory techniques are combined with CS, the aim is to improve the quality of care for patients with aMCI, considering that neuromodulation alternatives can delay the process of deterioration in each patient admitted.
The hypotheses in this study are: 1) The combined application of non-invasive neuromodulation techniques with cognitive stimulation will significantly improve the cognitive performance of patients with aMCI, compared to the single application of non-invasive neuromodulation techniques or cognitive stimulation alone. 2) There will be differences in the protein expression in the olfactory epithelial neural progenitor cells of patients with aMCI who are treated with some non-invasive neuromodulation techniques and those who only receive cognitive stimulation. 3) The soluble factors in the serum of patients with aMCI before and after treatment will differentially modulate microglia. 4) There will be differences in brain morphology such as cortical thickness and surface area, white matter integrity, as well as structural connectivity between different brain areas before and after treatment with non-invasive stimulation techniques. 5) There will be differences in the amplitude and latency of the MEP as well as changes in EEG of patients with aMCI who are treated with one of the non-invasive neuromodulation techniques and patients who only receive CS.
- Conditions
- Mild Cognitive Impairment
- Being tested
- 1. rTMS + CS, 2. rTMS Sham + CS, 3. tDCS + CS, 4. tDCS Sham + CS
- Keywords
- Mild cognitive impairment, Repetitive Transcranial Magnetic Stimulation rTMS, Transcranial Direct Current Stimulation tDCS, Neuromodulation Techniques, Amnestic Mild Cognitive Impairment, Cognitive Stimulation
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1. rTMS + CSDevice
In the first phase each participant will receive 15 sessions of rTMS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of rTMS and 1 session of CS per week for 12 weeks. Each session will consist of 10 trains of 10 stimuli, at a 5-Hz frequency and a stimulation intensity of 120% of the resting motor threshold.
rTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active/placebo 8-shape coil model MCF-B70.
Two surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The rTMS condition will be double-blinded through the use of a USB stick.
Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.
In total, each participant will receive 27 sessions of rTMS and 21 sessions of CS.
2. rTMS Sham + CSDevice
In the first phase each participant will receive 15 sessions of rTMS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham rTMS and 1 session of CS per week for 12 weeks.
In total, each participant will receive 27 sessions of Sham rTMS and 21 sessions of CS.
rTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active/placebo 8-shape coil model MCF-B70.
Two surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The sham condition will be double-blinded through the use of a USB stick.
Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.
In total, each participant will receive 27 sessions of rTMS and 21 sessions of CS.
3. tDCS + CSDevice
In the first phase each participant will receive 15 sessions of tDCS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of tDCS and 1 session of CS per week for 12 weeks. Each session will consist of the delivery of a weak direct current of 2mA for 30 minutes.
tDCS will be administered by the Sooma tDCS stimulator. The tDCS condition will be double-blinded, and a third operator will program the stimulator.
Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.
In total, each participant will receive 27 sessions of tCDS and 21 sessions of CS.
4. tDCS Sham + CSDevice
In the first phase each participant will receive 15 sessions of tDCS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham tDCS and 1 session of CS per week for 12 weeks.
tDCS will be administered by the Sooma tDCS stimulator. The sham condition will be double-blinded, and a third operator will program the stimulator.
Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council.
In total, each participant will receive 27 sessions of Sham tDCS and 21 sessions of CS.
| Study group | Role | What they receive |
|---|---|---|
| 1. rTMS + CS | Active comparator | Repetitive Transcranial Magnetic Stimulation (rTMS) + Cognitive Stimulation (CS) Receives: Device: 1. rTMS + CS |
| 2. rTMS Sham + CS | Sham comparator | Repetitive Transcranial Magnetic Stimulation Sham (rTMS Sham) + Cognitive Stimulation (CS) Receives: Device: 2. rTMS Sham + CS |
| 3. tDCS + CS | Active comparator | Transcranial Direct Current Stimulation (tDCS) + Cognitive Stimulation (CS) Receives: Device: 3. tDCS + CS |
| 4. tDCS Sham + CS | Sham comparator | Transcranial Direct Current Stimulation Sham (tDCS Sham) + Cognitive Stimulation (CS) Receives: Device: 4. tDCS Sham + CS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in orientation
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in language
Measured by the WAIS-IV vocabulary test. Score ranges from 1 to 19. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in language
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in verbal memory
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in verbal memory
Measured by Neuropsi Attention and Memory. Score ranges from 1 to 19. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in visual memory
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in visual memory
Measured by Neuropsi Attention and Memory. Score ranges from 1 to 19. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in visual-constructive abilities
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in visual-constructive abilities
Measured by Neuropsi Attention and Memory. Score ranges from 10 or less to 95. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in processing speed
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in processing speed
Measured by the Trail Making Test version A and B. Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in abstraction
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in verbal fluency
Measured by a verbal fluency test (semantic: animals and phonologic: F, A, S). Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in interference
Measured by the Stroop Test. Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in working memory
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in working memory
Measured by Trail Making Test version A and B. Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Measured: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Changes in Global Cognitive Function
Measured by Montreal Cognitive Assessment. Score ranges from 0 to 30 points. Higher scores mean better outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Global Cognitive Function
Measured by Screen for Cognitive Impairment in Psychiatry. Direct scores ranges from 37 to 115 points. Higher scores mean better outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in memory regarding situations and activities of daily life
Measure by Everyday Memory Questionnaire. Score ranges from 0 to 56. Higher scores mean worse outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later)
Changes in Global Clinical Impression
Measure by Clinical Impression Scale. Score ranges from 0 to 7. Higher scores mean worse outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Motor Evoked Potentials
Measured by MagVenture, Transcranial Magnetic Stimulation (TMS). Evaluation of cortical excitability and synaptic plasticity using a 5 Hz-rMTS (repetitive TMS). Increased amplitude and decreased latency parameters mean better outcomes after the intervention.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Olfactory Epithelial Neural Progenitor Cells
Measured by Neural Progenitor Cells Isolated. Quantification of the number of neural progenitor cells isolated from the olfactory epithelium. Increased number of neural progenitor cells after the intervention.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Solubles Factors of Serum
Measured by Exosome Analysis.To find a differential content of inflammatory markers in the exosomes before and after the intervention.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Functional Magnetic Resonance Imaging
Measured by Philips Magnetic Resonator, Ingenia 3T Equipment. The Sternberg task, which stimulates working memory and recent memory, will be used to observe changes Bold signal changes in gray matter, the hippocampus and white matter tracts.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Secondary outcomes (5)
Changes in Apathy symptoms
Measured by Apathy Evaluation Scale (self-report, informant report and clinician report). Score ranges from 18 to 72. Higher scores mean worse outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Depression
Measured by Yesavage Geriatric Depression Scale. Score ranges from 0 to 30. Higher scores mean worse outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in behavioral and psychological symptoms
Measured by Cummings Neuropsychiatric Inventory. Score ranges for frequency are 1 to 4, severity score ranges from 1 to 3 and distress score ranges from 0 to 4. Higher scores mean worse outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in electroencephalogram
Measured in each frequency band (delta, theta, alfa beta y gamma) before and after the intervention with the small-worldness measure, which will be obtained in order to observe the global optimization in the transmission of brain information. Likewise, will be complemented with an analysis of the clustering coefficient, local efficiency and global efficiency, calculating these measures in the F3 and F4 regions. To find changes in the small-worldness after the intervention.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in smell identification
Measured by the Brief Smell Identification Test. Score ranges from 0 to 12. Higher scores mean better outcomes.
Measured: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jun 2023
- Primary completion1 Jan 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparative, double-blind, randomized controlled clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ruth Alcalá Lozano, Dr., Principal investigator, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06467253
- Sponsor's protocol ID
- IC20137.0
- Status last verified
- Jun 2024
- First submitted
- 21 Mar 2024
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Non-invasive Neuromodulation Techniques as Synergistic Therapy to Cognitive Stimulation in Amnestic Mild Cognitive Impairment (aMCI): Genetic Characterization, Proteins Associated With Neurogenesis, Clinical, Neuroimaging and Electrophysiological Markers
- ClinicalTrials.gov ID
- NCT06467253
- Acronym / sponsor ID
- IC20137.0
- Conditions
- Mild Cognitive Impairment
- Keywords
- Mild cognitive impairment, Repetitive Transcranial Magnetic Stimulation rTMS, Transcranial Direct Current Stimulation tDCS, Neuromodulation Techniques, Amnestic Mild Cognitive Impairment, Cognitive Stimulation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Instituto Nacional de Psiquiatría Dr. Ramón de la FuenteUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a comparative, double-blind, randomized controlled clinical trial for people with Amnestic Mild Cognitive Impairment. The investigators will compare the effects of two non-invasive neuromodulation techniques (Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation) combined with cognitive stimulation. These non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare non-invasive techniques with cognitive stimulation CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow the investigators to characterize the participants; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells and solubles factors of serum; 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex by means of structural magnetic resonance imaging and the default mode network by means of functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude and latency in order to generate a response-to-treatment biomarker with neuromodulators in Mild Cognitive Impairment (MCI) and changes in electroencephalogram.
Detailed description
Mild Cognitive Impairment can be described as an intermediate stage between intact cognition and dementia, this study has become a global priority due to alarming changes in the population pyramid that place the world population at a higher risk of developing dementia. The global prevalence of MCI is between 15-20% in people over 60 years old. In 2012, a prevalence of MCI of 3.2% was found in Mexico City, which encourages the researchers to study this phenomenon to achieve early detection and create interventions that could delay the onset of dementia and even prevent it. Symptomatology is distinguished by deficits in one or more cognitive domains through formal tests applied repeatedly; the individual can manifest symptoms directly by identifying as different from a previous state and/or being corroborated by an informant. The amnestic cognitive impairment (aMCI) occurs when the cognitive failure is limited only to the domain of episodic memory. Generally, there is a slight functional impairment for complex tasks, but the basic and instrumental activities of daily life must be preserved. Behavioral and psychological symptoms (BPSD) can occur. Apathy, anxiety, and depression present in patients with mild cognitive impairment may represent an increased risk of dementia and in many cases, can be the first symptoms to appear. The evaluation is essential because BPSD are often controllable with treatment and appears in up to 77% of patients with MCI.
Despite the need to stop the progression to dementia, a MCI treatment is currently nonspecific, focused on associated events, with pharmacological and non-pharmacological measures aimed to reduce cognitive and neuropsychiatric symptoms. Therapeutic methods that promote neuroplasticity, for instance, cognitive stimulation (CS) and non-invasive neuromodulatory techniques such as Repetitive Transcranial Magnetic Stimulation (rTMS) and Transcranial Direct Current Stimulation (tDCS), optimize performance by stimulating the neural network distributed around a dysfunctional circuit, interacting with brain plasticity, and inducing or increasing compensatory mechanisms. This phenomenon could add to the cognitive reserve and interfere with the temporal evolution of the symptoms. Thereby, the rTMS and tDCS have been suggested as a possible treatment in aMCI. These non-invasive alternatives (rTMS and tDCS) have shown efficacy as a treatment in other disorders, but evidence is required on the efficacy, tolerability, and viability of the application in patients with amnesic MCI as well as the time that the effect of its application remains, which creates the need of further studies with maintenance phases.
In this project, the researchers propose a clinical trial for participants with risk of developing dementia using rTMS and tDCS added to CS in an effectiveness comparison using strict placebo control methods which will only be used with rTMS and tDCS, not with CS. The non-invasive neuromodulating techniques will be applied as a treatment alternative to be able to compare the techniques with CS alone, taking into account clinical and neuropsychological evaluations in addition to: 1) the known clinical risk factors (physical activity, comorbidities treatment, etc.) that allow to characterize patients; 2) characterize the participants with genetic biomarkers using the APOE4, CR1, COMT, TREM2 and ABCA7 genotype; 3) document the biological effects related to neurogenesis from olfactory epithelial neural progenitor cells isolated before and after treatment. In addition to the documentation of soluble factors secreted by olfactory epithelial neural progenitor cells, what is relevant to the knowledge of the influence of peripheral serum on microglia. This is crucial role in inflammation. The evaluations will be performed at different time points such as: Baseline (T0), after first phase of treatment (T1=15 sessions/week of tDCS+CS), after maintenance (T2=12 sessions/week of tDCS+CS), and follow-up phase (T3=1 year after treatment); 4) use hippocampal volume, cortical thickness of the medial temporal cortex and parietal cortex using structural magnetic resonance imaging and the default mode network using functional magnetic resonance imaging at rest as a biomarker of response to treatment and 5) associate the response to treatment with changes in Motor Evoked Potential (MEP) amplitude to generate a response-to-treatment biomarker with neuromodulators in MCI and changes in electroencephalogram (EEG).
Among the current limitations on knowledge of this disease, many studies use biomarkers to predict MCI or progression to dementia, and although most biomarkers are reported to be valuable in this setting, few are compared with each other, so this is currently difficult to understand the relative importance of the different biomarkers when used together. For this reason, the present project could be a contribution in the short and long term to detect changes that may or may not be related to each other and generate multiple lines of research.
Population aging will continue to increase and therefore there will be a greater number of people with aMCI. Currently, there is no treatment that prevents the progression of aMCI to AD, so the trend is to make earlier interventions. aMCI is a condition of opportunity because the cognitive reserve of the patients has not been exhausted, so developing studies with innovative treatments and few side effects that can change the evolution over time is important. To that end, understanding the etiology of this progression and designig treatments that delay or definitively stop aMCI are of importance to preserve the functionality of individuals with this condition.
Clinical trials with rTMS and tDCS carried out in aMCI have already shown favorable results regarding episodic memory, semantic memory, and speed of information processing. This trial will be able to contribute to the already reported findings that allow to identify better therapeutic approaches that support the standardization of the application of neuromodulatory techniques. Besides, the possible additive effect of neuromodulatory techniques and CS is well known, but no studies are comparing between diferent interventions with each other. The genetic characterization will be obtained, an experimental biomarker of secretion proteins from olfactory epithelial neural progenitor cells together with the analysis of the neurogenic process occurring in the olfactory epithelium will be generated, an experimental biomarker of serum and the effects soluble factors contained in serum on microglia will be generated, neuroimaging and produce neurophysiological measures considered as possible neuroplasticity biomarkers (MEPs and EEG) associated with the response to non-pharmacological treatment will be recorded and evaluated if the parameters are related to clinical and cognitive characteristics. With this therapeutic approach where non-invasive neuromodulatory techniques are combined with CS, the aim is to improve the quality of care for patients with aMCI, considering that neuromodulation alternatives can delay the process of deterioration in each patient admitted.
The hypotheses in this study are: 1) The combined application of non-invasive neuromodulation techniques with cognitive stimulation will significantly improve the cognitive performance of patients with aMCI, compared to the single application of non-invasive neuromodulation techniques or cognitive stimulation alone. 2) There will be differences in the protein expression in the olfactory epithelial neural progenitor cells of patients with aMCI who are treated with some non-invasive neuromodulation techniques and those who only receive cognitive stimulation. 3) The soluble factors in the serum of patients with aMCI before and after treatment will differentially modulate microglia. 4) There will be differences in brain morphology such as cortical thickness and surface area, white matter integrity, as well as structural connectivity between different brain areas before and after treatment with non-invasive stimulation techniques. 5) There will be differences in the amplitude and latency of the MEP as well as changes in EEG of patients with aMCI who are treated with one of the non-invasive neuromodulation techniques and patients who only receive CS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Comparative, double-blind, randomized controlled clinical trial.
| Arm | Type | Receives |
|---|---|---|
| 1. rTMS + CS | Active comparator | Device: 1. rTMS + CSRepetitive Transcranial Magnetic Stimulation (rTMS) + Cognitive Stimulation (CS) |
| 2. rTMS Sham + CS | Sham comparator | Device: 2. rTMS Sham + CSRepetitive Transcranial Magnetic Stimulation Sham (rTMS Sham) + Cognitive Stimulation (CS) |
| 3. tDCS + CS | Active comparator | Device: 3. tDCS + CSTranscranial Direct Current Stimulation (tDCS) + Cognitive Stimulation (CS) |
| 4. tDCS Sham + CS | Sham comparator | Device: 4. tDCS Sham + CSTranscranial Direct Current Stimulation Sham (tDCS Sham) + Cognitive Stimulation (CS) |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Being vaccinated against the SARS-COV2 virus.
- Speak Spanish fluently.
- Level of schooling greater than or equal to 6 years.
- Amnestic mild cognitive impairment established by clinical examination performed by the treating physician (MoCA score: 19-25 points for probable aMCI) (based on the National Institute on Aging and Alzheimer's Association (NIA/AA) criteria, 2011).
- Adequate visual and auditory acuity to perform neuropsychological tests and cognitive rehabilitation.
Key exclusion criteria (6 listed)
- Any neurological disease that raises suspicion of cognitive failure other than Alzheimer's disease, such as Parkinson's, multi-infarct dementia, Huntington's disease, hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, history of trauma craniocerebral with loss of alertness.
- Participants with a history of severe psychiatric disorders according to DSM-5 (bipolar disorder, schizophrenia, chronic depression) or with psychotic features, agitation, or behavioral problems in the last three months that could lead to difficulties in meeting the protocol.
- History of psychoactive substance abuse and current alcohol consumption with a pattern of abuse or dependence in the last two years.
- Participants with alterations in a conventional electroencephalogram (paroxysmal phenomena identified by a neurophysiologist).
- Participants with pacemakers, intracranial metal objects, or history of brain surgery, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 1. rTMS + CSIn the first phase each participant will receive 15 sessions of rTMS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of rTMS and 1 session of CS per week for 12 weeks. Each session will consist of 10 trains of 10 stimuli, at a 5-Hz frequency and a stimulation intensity of 120% of the resting motor threshold. rTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active/placebo 8-shape coil model MCF-B70. Two surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The rTMS condition will be double-blinded through the use of a USB stick. Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council. In total, each participant will receive 27 sessions of rTMS and 21 sessions of CS. | Device | 1. rTMS + CS |
| 2. rTMS Sham + CSIn the first phase each participant will receive 15 sessions of rTMS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham rTMS and 1 session of CS per week for 12 weeks. In total, each participant will receive 27 sessions of Sham rTMS and 21 sessions of CS. rTMS will be administered by a MagPro R30 stimulator (MagVenture) and an active/placebo 8-shape coil model MCF-B70. Two surface electrodes will be employed to replicate rTMS skin sensations near the stimulation site. The sham condition will be double-blinded through the use of a USB stick. Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council. In total, each participant will receive 27 sessions of rTMS and 21 sessions of CS. | Device | 2. rTMS Sham + CS |
| 3. tDCS + CSIn the first phase each participant will receive 15 sessions of tDCS and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of tDCS and 1 session of CS per week for 12 weeks. Each session will consist of the delivery of a weak direct current of 2mA for 30 minutes. tDCS will be administered by the Sooma tDCS stimulator. The tDCS condition will be double-blinded, and a third operator will program the stimulator. Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council. In total, each participant will receive 27 sessions of tCDS and 21 sessions of CS. | Device | 3. tDCS + CS |
| 4. tDCS Sham + CSIn the first phase each participant will receive 15 sessions of tDCS Sham and 9 sessions of CS divided in 3 weeks, in the maintenance phase each participant will receive 1 session of Sham tDCS and 1 session of CS per week for 12 weeks. tDCS will be administered by the Sooma tDCS stimulator. The sham condition will be double-blinded, and a third operator will program the stimulator. Cognitive stimulation will be a Mexican adaptation of the "Memory Training and Cognitive Stimulation for Mild Cognitive Impairment" from the Center for the Prevention of Cognitive Impairment of the Madrid City Council. In total, each participant will receive 27 sessions of Sham tDCS and 21 sessions of CS. | Device | 4. tDCS Sham + CS |
Primary outcome
Changes in orientation
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in language
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the WAIS-IV vocabulary test. Score ranges from 1 to 19. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Changes in language
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in verbal memory
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in verbal memory
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by Neuropsi Attention and Memory. Score ranges from 1 to 19. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Changes in visual memory
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in visual memory
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by Neuropsi Attention and Memory. Score ranges from 1 to 19. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Changes in visual-constructive abilities
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in visual-constructive abilities
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by Neuropsi Attention and Memory. Score ranges from 10 or less to 95. Direct scores are converted to standardized scores. Higher scores mean better outcomes.
Changes in processing speed
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in processing speed
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Trail Making Test version A and B. Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in abstraction
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in verbal fluency
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by a verbal fluency test (semantic: animals and phonologic: F, A, S). Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in interference
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Stroop Test. Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in working memory
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by the Barcelona Test. Score ranges from 10 or less to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in working memory
Time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).
Measured by Trail Making Test version A and B. Score ranges from 5 to 95. Direct scores are converted to percentile. Higher scores mean better outcomes.
Changes in Global Cognitive Function
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measured by Montreal Cognitive Assessment. Score ranges from 0 to 30 points. Higher scores mean better outcomes.
Changes in Global Cognitive Function
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measured by Screen for Cognitive Impairment in Psychiatry. Direct scores ranges from 37 to 115 points. Higher scores mean better outcomes.
Changes in memory regarding situations and activities of daily life
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later)
Measure by Everyday Memory Questionnaire. Score ranges from 0 to 56. Higher scores mean worse outcomes.
Changes in Global Clinical Impression
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measure by Clinical Impression Scale. Score ranges from 0 to 7. Higher scores mean worse outcomes.
Changes in Motor Evoked Potentials
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measured by MagVenture, Transcranial Magnetic Stimulation (TMS). Evaluation of cortical excitability and synaptic plasticity using a 5 Hz-rMTS (repetitive TMS). Increased amplitude and decreased latency parameters mean better outcomes after the intervention.
Changes in Olfactory Epithelial Neural Progenitor Cells
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measured by Neural Progenitor Cells Isolated. Quantification of the number of neural progenitor cells isolated from the olfactory epithelium. Increased number of neural progenitor cells after the intervention.
Changes in Solubles Factors of Serum
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measured by Exosome Analysis.To find a differential content of inflammatory markers in the exosomes before and after the intervention.
Changes in Functional Magnetic Resonance Imaging
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Measured by Philips Magnetic Resonator, Ingenia 3T Equipment. The Sternberg task, which stimulates working memory and recent memory, will be used to observe changes Bold signal changes in gray matter, the hippocampus and white matter tracts.
5 secondary outcomes
Changes in Apathy symptoms
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in Depression
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in behavioral and psychological symptoms
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in electroencephalogram
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Changes in smell identification
Time frame: Baseline, after first phase (3 weeks), after maintenance (15 weeks) and in follow-up phase (1 year later).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ruth Alcalá Lozano, Dr. principal investigator
Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1. rTMS + CS and 3. tDCS + CS in people with Mild Cognitive Impairment, run by Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Alcalá Lozano, Dr. (5541605065 ext. 5065, ruthalcala@inprf.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in orientation (time frame: Baseline, after maintenance (15 weeks), and in follow-up phase (1 year later).). The study lists 24 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.