Semantic DementiaSTIM-SDNCT03481933
Evaluation of a Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia
A study testing Transcranial stimulation in people with Semantic Dementia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Within the spectrum of fronto-temporal lobar degeneration (FTLD) semantic dementia (SD) causes profound language dysfunction. SD damages semantic processing typically in the temporal poles (anterior temporal lobes, ATL). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Semantic Dementia
- What is being tested?
- Transcranial stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 16 May 2018to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SD-Patients:
- Patients fulfilling the international diagnosis criteria of SD (Gorno-Tempini et al., 2011): fluent speech, single word comprehension and naming deficit, +/- object recognition deficits, +/- surface agraphia or alexia. Absence of phonemic paraphasias, agrammatism and word apraxia.
- Age > 18 years old.
- Patients have given their informed written consent.
- Affiliation to a social security regime.
- Healthy controls:
Show all 10Show fewer
- Age >18 years old
- Subjects have given their informed written consent.
- Subjects selected according to the matching criteria (age, sex, handedness and number of years of education).
- Affiliation to a social security regime
Who cannot join
- SD-Patients:
- MADRS ≥ 20 (major depressive syndrome according to the DSM-IV-R criteria)
- MMS < 10/30
- FAB < 7/18
- BDAE aphasia severity rating scale < 3/5
- Patients not having French as their mother tongue
Show all 18Show fewer
- Other neurological pathology or general disorder or major physical deficits than can interfere with cognitive functioning
- MRI or PET contraindication, 18-FDG contraindication
- Cerebral MRI data compatible with a pathological process other than the one related to SD (Vascular, traumatic, tumoral, infectious, or metabolic brain injury). A moderate or discrete leukoaraiosis will not be considered as a non- inclusion criterion (patients with a Fazekas and Schmidt [Fazekas et al., 1998a; fazekas et al., 1998b],stage >2 for hypersignals of the periventricular and deep white matter will not be included)
- The patient should not participate simultaneously in another brain therapeutic trial (possibility of bias between stimulation and evaluation of the effect on language / semantic processes)
- - tDCS contraindications: epilepsy antecedents, presence of epilepsy risk factors (known alcoholism or metabolic troubles, antecedents of head injury or chirurgical intervention on the brain or the skull), skin lesions of the scalp, skull metal implants.
- - Patients under curatorship or tutorship
- - Women whose pregnancy is known or who do not have effective contraception if they are of reproductive age (checked by urinary test), breastfeeding.
- Healthy controls:
- Subjects not having French as their mother tongue
- Subjects having a neurological or psychiatric disease or major deficits than can interfere with cognitive functioning
- MRI or PET contraindication, 18-FDG contraindication
- Women whose pregnancy is known or who do not have effective contraception if they are of reproductive age (checked by urinary test), breastfeeding.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales
Paris, 75013
Marc TEICHMANN, Md-PhD, 0033 (1) 42 16 75 34, marc.teichmann@aphp.fr
- Recruiting
Hôpital de la Pitié-Salpétrière
Paris, 75013
Richard Levy, MD, 01 42 16 00 59, richard.levy@psl.aphp.fr
Richard Levy, MD
About this study
Official title: Investigation of the Therapeutic Value of Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia
Within the spectrum of fronto-temporal lobar degeneration (FTLD) semantic dementia (SD) causes profound language dysfunction. SD damages semantic processing typically in the temporal poles (anterior temporal lobes, ATL). It is an early onset disease (often before 65 years of age) affecting about 4000 patients in France and for which no validated treatment is available.
For several years a growing number of studies have explored the effects of transcranial stimulation (TCS) on aphasic patients following stroke. Several studies have targeted left-sided language areas and/or homotopical right-sided regions with excitatory or inhibitory TCS, respectively, according to the principle of inter-hemispheric inhibition. In addition, repetitive multi-day TCS has provided evidence for long-lasting language effects (>6 months) presumably linked to stimulation-induced neuroplasticity. Such investigations have provided promising results and have demonstrated that the stimulation site is a determining factor by showing that stimulation of cortical areas belonging to the language network usually results in more convincing effects than stimulating areas outside that network. Despite these findings the use of TCS in degenerative language diseases, such as primary progressive aphasias including SD, has only been explored in few small cohort studies and, surprisingly, they have not targeted language-related cortices.
This project proposes the application of multi-day repetitive TCS with direct current (tDCS) in a large population of SD patients (N=60). It is built on a exploratory investigation of our team which has used three single tDCS sessions in a double-blind sham-controlled study. Excitatory and inhibitory tDCS to the left and right temporal pole, respectively, demonstrated highly significant transient effects (20 min) on semantic processing in 12 SD patients, providing 'proof of concept' and the rationale for this project. The aim here consists of using repetitive multi-day tDCS for a potential therapeutic outcome leading to long-lasting semantic improvement via neuroplasticity. The project is grounded on 2 hypotheses: i) tDCS to temporal poles (left-excitatory, right-inhibitory) reactivates semantic processing in SD, ii) repetitive tDCS during ten days could induce neuroplasticity and therapeutic language improvement.
Read the detailed description
Main objective and evaluation criteria:
To evaluate the potential therapeutic efficacy of repetitive tDCS during 10 days on language/semantic impairment in SD via a double-blind sham-controlled study design. The evaluation criteria will be a significant improvement of language/semantic performances two weeks after tDCS as compared to base-line (before tDCS), contrasting subgroups receiving left-excitatory or right-inhibitory tDCS vs. sham tDCS
Secondary objectives and evaluation criteria:
- Assess the time course of potential language/semantic improvement through the application of four follow-up time-points: base-line (max one week before tDCS), three days, two weeks and four months after tDCS. The evaluation criteria will be significant improvement/modulation of language/semantic performances, comparing performances at the four time-points.
- Assess brain markers which could reflect stimulation-induced neuroplasticity. Evaluation criteria will be significant modulation of cortical metabolism (FDG-PET) and functional connectivity (fMRI resting-state) comparing base-line and the 'two-week' time-point.
- Compare left-excitatory and right-inhibitory tDCS to reveal the most efficient stimulation modality. Evaluation criteria will be a detection of a potential outcome difference between left-excitatory and right-inhibitory tDCS on the performance within the different language/semantic tasks.
- Improve the understanding of the semantic roles of the left and right temporal pole, and their potential anatomical connectivity, by comparing left and right temporal pole stimulation and using MRI-based fiber tracking. 4) Improve the understanding of the semantic roles of the left and right temporal pole, and their potential anatomical connectivity, by comparing left and right temporal pole stimulation and using MRI-based fiber tracking.
Experimental design :
10 days of stimulation (20min, 2mA). Four language/semantic evaluations: base-line; 3 days; 2 weeks; 4 months post-tDCS. Two MRI/PET acquisitions: pre-stimulation (base-line); 2 weeks post-tDCS
Population :
Patients with semantic dementia (SD). Healthy controls for normative measures (no tDCS for controls)
Testing treatment :
tDCS (specific device) : NE STARSTIM-ENOBIO 8 channels.
Practical procedure :
The duration of the study will be 41 months; 36 months being dedicated to patient inclusion. Participation duration of a patient will be of 4 months and 1 week to 4 months and 3 weeks maximum. First, patients will undergo a series of standardized neuropsychological and language tests that are included in routine care and inclusion criteria will be checked. After inclusion, the base-line visit will comprehend 1) MRI/PET in the Nuclear Medicine Service (CHU Pitié Salpêtrière), and 2) language/semantic tasks at the Department of Neurology (CHU Pitié Salpêtrière). Subsequently the ten stimulation sessions will be scheduled. They will take place in the Institute of Memory and Alzheimer's disease (Department of Neurology, CHU Pitié Salpêtrière) during two consecutive weeks (20 minutes of tDCS). The tDCS sessions will be followed by three time-point visits: 3 days (time-point 2) and two weeks (time-point 3) after the last stimulation session patients will undergo the language/semantic tasks. At time point 3 the second MRI/PET acquisition will take place. Finally, the visit of time-point 4 will be at four months after the last tDCS session, dedicated to a last application of language/semantic tasks.
Selected number of subjects:
80 SD patients selected in order to have 60 randomized into three arms (20 patients/arm).Two arms receiving active tDCS versus one receiving sham tDCS.
20 healthy volunteers will be included (participants will provide normative language/semantic scores and MRI/PET measures; they will not undergotDCS).
Number of centers: 3 centers in France (Paris)
Research duration:
Inclusion period: 36 months Participation period (Selection/inclusion, tDCS sessions and evaluation at 4 time-points): 4 months and 1 week to 4 months and 3 weeks Total duration: 41 months
Funding source: AP-HP (Assistance Publique des Hôpitaux de Paris).
- Conditions
- Semantic Dementia
- Being tested
- Transcranial stimulation
- Medical subject headings
- Frontotemporal Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial stimulationDevice
- 10 days of stimulation (20min, 1.59mA) in double-blind sham-controlled. 3 arms (N=20 in each arm):
- left-excitatory tDCS (N=20)
- right-inhibitory tDCS (N=20)
- sham tDCS (N=20)
- 4 language/semantic evaluations: base-line; 3 days; 2 weeks; 4 months post-tDCS
- 2 MRI/PET acquisitions: pre-stimulation (base-line); 2 weeks post-tDCS
| Study group | Role | What they receive |
|---|---|---|
| 1:left-excitatory tDCS | Experimental | 20 SD patients who receive left-excitatory trans cranial stimulation Receives: Device: Transcranial stimulation |
| 2:right-inhibitory tDCS | Active comparator | 20 SD patients who receive right-inhibotory trans cranial stimulation Receives: Device: Transcranial stimulation |
| 3:sham tDCS | Sham comparator | 20 SD patients who receive sham stimulation Receives: Device: Transcranial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Significant improvement of semantic performances on the experimental 'semantic matching test'
The 'semantic matching test' assesses semantic processing in the verbal and visual modality. Outcome measure will be the difference between performance on the test at base line and two weeks after tDCS: composite score of accuracy on the test.
Measured: 15 days
Secondary outcomes (3)
Significant modulation of semantic performances on the 'semantic matching test'
Outcome measures will be the difference of performance on the test between base line and 1) 3 days after tDCS, 2) 4 months after tDCS: composite score of accuracy on the test.
Measured: 3 days, 4 months
significant modulation of cortical metabolism and functional connectivity
significant modulation of cortical metabolism on FDG-PET and functional connectivity on fMRI resting-state, comparing base-line and the two weeks after tDCS
Measured: 2 weeks
Detection of a potential outcome difference between left-excitatory and right-inhibitory tDCS
performance difference on the accuracy score of the semantic matching task comparing left and right tDCS
Measured: 15 days, 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2018
- Study start16 May 2018
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Semantic DementiaStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- left-excitatory tDCS ; right-inhibitory tDCS; sham tDCS (placebo)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03481933
- Sponsor's protocol ID
- P160937J
- Acronym
- STIM-SD
- Status last verified
- Mar 2023
- First submitted
- 9 Mar 2018
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanches C, Levy R, Benisty S, Volpe-Gillot L, Habert MO, Kas A, Stroer S, Pyatigorskaya N, Kaglik A, Bourbon A, Dubois B, Migliaccio R, Valero-Cabre A, Teichmann M. Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial. Trials. 2019 Nov 20;20(1):632. doi: 10.1186/s13063-019-3613-z.
PubMed 31747967
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Therapeutic Value of Transcranial Stimulation With Direct Current on Language Disorders in Semantic Dementia
- ClinicalTrials.gov ID
- NCT03481933
- Acronym / sponsor ID
- STIM-SD / P160937J
- Conditions
- Semantic Dementia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 16 May 2018 (actual)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 29 Mar 2018 (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.
Within the spectrum of fronto-temporal lobar degeneration (FTLD) semantic dementia (SD) causes profound language dysfunction. SD damages semantic processing typically in the temporal poles (anterior temporal lobes, ATL). It is an early onset disease (often before 65 years of age) affecting about 4000 patients in France and for which no validated treatment is available.
For several years a growing number of studies have explored the effects of transcranial stimulation (TCS) on aphasic patients following stroke. Several studies have targeted left-sided language areas and/or homotopical right-sided regions with excitatory or inhibitory TCS, respectively, according to the principle of inter-hemispheric inhibition. In addition, repetitive multi-day TCS has provided evidence for long-lasting language effects (>6 months) presumably linked to stimulation-induced neuroplasticity. Such investigations have provided promising results and have demonstrated that the stimulation site is a determining factor by showing that stimulation of cortical areas belonging to the language network usually results in more convincing effects than stimulating areas outside that network. Despite these findings the use of TCS in degenerative language diseases, such as primary progressive aphasias including SD, has only been explored in few small cohort studies and, surprisingly, they have not targeted language-related cortices.
This project proposes the application of multi-day repetitive TCS with direct current (tDCS) in a large population of SD patients (N=60). It is built on a exploratory investigation of our team which has used three single tDCS sessions in a double-blind sham-controlled study. Excitatory and inhibitory tDCS to the left and right temporal pole, respectively, demonstrated highly significant transient effects (20 min) on semantic processing in 12 SD patients, providing 'proof of concept' and the rationale for this project. The aim here consists of using repetitive multi-day tDCS for a potential therapeutic outcome leading to long-lasting semantic improvement via neuroplasticity. The project is grounded on 2 hypotheses: i) tDCS to temporal poles (left-excitatory, right-inhibitory) reactivates semantic processing in SD, ii) repetitive tDCS during ten days could induce neuroplasticity and therapeutic language improvement.
Detailed description
Main objective and evaluation criteria:
To evaluate the potential therapeutic efficacy of repetitive tDCS during 10 days on language/semantic impairment in SD via a double-blind sham-controlled study design. The evaluation criteria will be a significant improvement of language/semantic performances two weeks after tDCS as compared to base-line (before tDCS), contrasting subgroups receiving left-excitatory or right-inhibitory tDCS vs. sham tDCS
Secondary objectives and evaluation criteria:
- Assess the time course of potential language/semantic improvement through the application of four follow-up time-points: base-line (max one week before tDCS), three days, two weeks and four months after tDCS. The evaluation criteria will be significant improvement/modulation of language/semantic performances, comparing performances at the four time-points.
- Assess brain markers which could reflect stimulation-induced neuroplasticity. Evaluation criteria will be significant modulation of cortical metabolism (FDG-PET) and functional connectivity (fMRI resting-state) comparing base-line and the 'two-week' time-point.
- Compare left-excitatory and right-inhibitory tDCS to reveal the most efficient stimulation modality. Evaluation criteria will be a detection of a potential outcome difference between left-excitatory and right-inhibitory tDCS on the performance within the different language/semantic tasks.
- Improve the understanding of the semantic roles of the left and right temporal pole, and their potential anatomical connectivity, by comparing left and right temporal pole stimulation and using MRI-based fiber tracking. 4) Improve the understanding of the semantic roles of the left and right temporal pole, and their potential anatomical connectivity, by comparing left and right temporal pole stimulation and using MRI-based fiber tracking.
Experimental design :
10 days of stimulation (20min, 2mA). Four language/semantic evaluations: base-line; 3 days; 2 weeks; 4 months post-tDCS. Two MRI/PET acquisitions: pre-stimulation (base-line); 2 weeks post-tDCS
Population :
Patients with semantic dementia (SD). Healthy controls for normative measures (no tDCS for controls)
Testing treatment :
tDCS (specific device) : NE STARSTIM-ENOBIO 8 channels.
Practical procedure :
The duration of the study will be 41 months; 36 months being dedicated to patient inclusion. Participation duration of a patient will be of 4 months and 1 week to 4 months and 3 weeks maximum. First, patients will undergo a series of standardized neuropsychological and language tests that are included in routine care and inclusion criteria will be checked. After inclusion, the base-line visit will comprehend 1) MRI/PET in the Nuclear Medicine Service (CHU Pitié Salpêtrière), and 2) language/semantic tasks at the Department of Neurology (CHU Pitié Salpêtrière). Subsequently the ten stimulation sessions will be scheduled. They will take place in the Institute of Memory and Alzheimer's disease (Department of Neurology, CHU Pitié Salpêtrière) during two consecutive weeks (20 minutes of tDCS). The tDCS sessions will be followed by three time-point visits: 3 days (time-point 2) and two weeks (time-point 3) after the last stimulation session patients will undergo the language/semantic tasks. At time point 3 the second MRI/PET acquisition will take place. Finally, the visit of time-point 4 will be at four months after the last tDCS session, dedicated to a last application of language/semantic tasks.
Selected number of subjects:
80 SD patients selected in order to have 60 randomized into three arms (20 patients/arm).Two arms receiving active tDCS versus one receiving sham tDCS.
20 healthy volunteers will be included (participants will provide normative language/semantic scores and MRI/PET measures; they will not undergotDCS).
Number of centers: 3 centers in France (Paris)
Research duration:
Inclusion period: 36 months Participation period (Selection/inclusion, tDCS sessions and evaluation at 4 time-points): 4 months and 1 week to 4 months and 3 weeks Total duration: 41 months
Funding source: AP-HP (Assistance Publique des Hôpitaux de Paris).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- left-excitatory tDCS ; right-inhibitory tDCS; sham tDCS (placebo)
| Arm | Type | Receives |
|---|---|---|
| 1:left-excitatory tDCS | Experimental | Device: Transcranial stimulation20 SD patients who receive left-excitatory trans cranial stimulation |
| 2:right-inhibitory tDCS | Active comparator | Device: Transcranial stimulation20 SD patients who receive right-inhibotory trans cranial stimulation |
| 3:sham tDCS | Sham comparator | Device: Transcranial stimulation20 SD patients who receive sham stimulation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Patients fulfilling the international diagnosis criteria of SD (Gorno-Tempini et al., 2011): fluent speech, single word comprehension and naming deficit, +/- object recognition deficits, +/- surface agraphia or alexia. Absence of phonemic paraphasias, agrammatism and word apraxia.
- Age > 18 years old.
- Patients have given their informed written consent.
- Affiliation to a social security regime.
- Age >18 years old
Key exclusion criteria (18 listed)
- MADRS ≥ 20 (major depressive syndrome according to the DSM-IV-R criteria)
- MMS < 10/30
- FAB < 7/18
- BDAE aphasia severity rating scale < 3/5
- Patients not having French as their mother tongue
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 |
|---|---|---|
| Transcranial stimulation1. 10 days of stimulation (20min, 1.59mA) in double-blind sham-controlled. 3 arms (N=20 in each arm): * left-excitatory tDCS (N=20) * right-inhibitory tDCS (N=20) * sham tDCS (N=20) 2. 4 language/semantic evaluations: base-line; 3 days; 2 weeks; 4 months post-tDCS 3. 2 MRI/PET acquisitions: pre-stimulation (base-line); 2 weeks post-tDCS | Device | 1:left-excitatory tDCS, 2:right-inhibitory tDCS, 3:sham tDCS |
Primary outcome
Significant improvement of semantic performances on the experimental 'semantic matching test'
Time frame: 15 days
The 'semantic matching test' assesses semantic processing in the verbal and visual modality. Outcome measure will be the difference between performance on the test at base line and two weeks after tDCS: composite score of accuracy on the test.
3 secondary outcomes
Significant modulation of semantic performances on the 'semantic matching test'
Time frame: 3 days, 4 months
significant modulation of cortical metabolism and functional connectivity
Time frame: 2 weeks
Detection of a potential outcome difference between left-excitatory and right-inhibitory tDCS
Time frame: 15 days, 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2024.
- Derived from this study: PubMed 31747967Sanches C, Levy R, Benisty S, Volpe-Gillot L, Habert MO, Kas A, Stroer S, Pyatigorskaya N, Kaglik A, Bourbon A, Dubois B, Migliaccio R, Valero-Cabre A, Teichmann M. Testing the therapeutic effects of transcranial direct current stimulation (tDCS) in semantic dementia: a double blind, sham controlled, randomized clinical trial. Trials. 2019 Nov 20;20(1):632. doi: 10.1186/s13063-019-3613-z.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Département de Neurologie - Centre des maladies neurologiques, cognitives et comportementales
Paris, France
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial stimulation in people with Semantic Dementia, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
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 10 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 17 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Significant improvement of semantic performances on the experimental 'semantic matching test' (time frame: 15 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03481933, which also lists 1 linked publication.
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 17 Jan 2024.