Mild Cognitive ImpairmentTMSMemOldNCT01292382
Effects of rTMS on the Cognition of Elderly With Mild Memory Complaints
A study testing Repetitive transcranial magnetic stimulation in people with Mild Cognitive Impairment, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
Memory is constituted by a set of mental abilities of information processing that will be available at a later time. Flawless performance depends on several brain systems and other cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the production capacity and quality of life. Read more about this study
- Who is it for?
- Ages 60 to 74 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Repetitive transcranial magnetic stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2010to Jul 2012
- 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 60 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of both sexes
- Aged between 60 and 74 years
- Schooling ≥ 4 years
- Performance on neuropsychological tests of up to 1.5 standard deviations below normal for age and education
- Signing an informed consent by the participant or his guardian.
Who cannot join
- Prior diagnosis of dementia.
- Any psychiatric disorder, except for mild depression for at least six months.
- Shall be excluded those with scores> 12 on the Hamilton scale.
- History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery
- Clinical or neurological diseases with an impact on cognitive ability
- Neurodegenerative central nervous system (eg Parkinson's disease)
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- Alcohol and other drug dependency with abstinence for less than a year
- Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants
- Chronic use of benzodiazepines with abstinence for less than six months
- Use of vitamin supplements (multivitamins, folic acid, vitamin B12), ginkgo biloba
- Severe uncontrolled organic disease that could interfere in the conduct of the study, such as cancer, heart disease, digestive disorders, diabetes mellitus type I or type II, uncontrolled dyslipidemia etc.
- Sensory disabilities, intellectual, preventing them from adequately perform the necessary tests to assess cognitive function
- Cerebrovascular disease based on Hachinsky score.
- History of head trauma.
- Any other condition that in the opinion of the investigator makes problematic the inclusion of the patient in a trial of this nature, as well as patients who do not adhere or not to cooperate.
- Worsening of the primary symptoms during the treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
University of Sao Paulo General Hospital
São Paulo, São Paulo, 05453-010
Hellen Marra, +55 11 3069 8159, hellen.marra@usp.br
Marco Marcolin, +55 11 3069 8159, marcolin@usp.br
About this study
Official title: Effects of rTMS on the Cognition of Elderly With Cognitive Impairment no Dementia ( CIND )
Memory is constituted by a set of mental abilities of information processing that will be available at a later time. Flawless performance depends on several brain systems and other cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the production capacity and quality of life. Such deficits represent variations of normal , and may stabilize,or even better progress. Include multiple cognitive domains, such as working and episodic memory, and attention. Despite the heterogeneity of the nature and severity of these deficits, common characteristics were observed in neuropsychological assessment of that population, for example, reduction in processing speed. There is an important gap in the therapeutic approach of these individuals.
Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with potential to improve memory and cognition activating networks that operate on memory or other networks that interfere with cognitive performance. The technique relies on generating a variable magnetic field originated from an alternating electric current applied to the human skull reaching focal cortical regions.
This study is a sham-controlled clinical trial, randomized, double-blind study. It will be evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global cognition (memory, attention, language, executive functions, planning, logical reasoning, calculation and visual-spatial perception), especially memory, of elderly individuals with mild cognitive impairment, included in the domain of cognitive impairment no dementia (CIND).
Read the detailed description
Subjects:
- Eligibility criteria:
- Male and female participants
- Older adults aged 60-74 years
- Education ≥ 4 years
- Performance on neuropsychological tests below normal for age and education
- Availability to attend the sessions of the application of TMS and neuropsychological assessments
- Signing an informed consent by the participant or his guardian
II. No eligibility criteria:
- Prior diagnosis of dementia
- Any psychiatric disorder, except for mild depression in remission for at least 6 months. Shall be excluded those with scores > 12 on the Hamilton Depression Scale
- History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery
- Clinical or neurological diseases with impact on cognitive ability
- Neurodegenerative central nervous system disease(eg. Parkinson Disease)
- Alcohol and other drug abstinence for less than one year
- Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants
- Chronic use of benzodiazepines with abstinence for less than 6 months
- Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, congestive heart disease, digestive disorders, diabetes mellitus type I or type II, dyslipidemia etc.
- Sensory impairments(to guarantee a adequate performance in the tests to evaluate cognitive functions)
- Magnetic resonance imaging of the brain with evidence of lacunar or large vessels infarctions, cerebral hemorrhage
- Hachinski Ischemic score of > 7 (or modified by Loeb > 5) 14. Any other condition that in the opinion of the investigator becomes problematic inclusion of the patient in a trial of this nature, as well as patients who do not adhere or do not cooperate.
III. Outcome measures:
Will be considered as an outcome measure a variation greater than or equal to 10% compared to baseline scores of neuropsychological tests, which will be applied on three occasions: immediately before (T0), after treatment (T2) and 4 weeks after the end of it (T3).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Repetitive transcranial magnetic stimulation
- Keywords
- Elderly, Memory, Cognition, Repetitive transcranial magnetic 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.
Repetitive transcranial magnetic stimulationDevice
Also called Active rTMS group, Sham rTMS group
Intensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 trains Duration of trains: 5 seconds Interval: 25 seconds Number of sessions: 10 sessions Duration of intervention: two consecutive weeks
Repetitive transcranial magnetic stimulationDevice
Also called Arm 1: Active rTMS, Arm 2: Sham rTMS
Intensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 Duration of trains: 5 seconds Interval inter trains: 25 seconds Number of pulses each session: 2.000 Total number of pulses: 20.000
| Study group | Role | What they receive |
|---|---|---|
| rTMS versus Sham | Sham comparator | rTMS: active coil Sham: inactive coil Receives: Device: Repetitive transcranial magnetic stimulation |
| rTMS versus sham | Active comparator | rTMS group: active coil Sham group: inactive coil Receives: Device: Repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints
Neuropsychological tests - RBMT (Rivermead Behavioral and Memory Test)
Measured: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Secondary outcomes (1)
Repetitive transcranial magnetic stimulation improves global cognition of elderly with memory complaints
Performance on neuropsychological tests - STROOP, Trails 1 and 2, mini mental status exam (MMSE), clock drawing test, Wechsler, WAISS III, verbal fluency.
Measured: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2011 (estimated)
- Study startNov 2010
- Primary completionNov 2010
- Study completionJul 2012 (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.
- More trials run by University of Sao Paulo General HospitalThe 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marco Marcolin, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01292382
- Sponsor's protocol ID
- rTMSCogOld
- Acronym
- TMSMemOld
- Status last verified
- Aug 2010
- First submitted
- 5 Oct 2010
- Last updated
- 21 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of rTMS on the Cognition of Elderly With Cognitive Impairment no Dementia ( CIND )
- ClinicalTrials.gov ID
- NCT01292382
- Acronym / sponsor ID
- TMSMemOld / rTMSCogOld
- Conditions
- Mild Cognitive Impairment
- Keywords
- Elderly, Memory, Cognition, Repetitive transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jul 2012 (estimated)
- First posted
- 9 Feb 2011 (estimated)
- 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.
Memory is constituted by a set of mental abilities of information processing that will be available at a later time. Flawless performance depends on several brain systems and other cognitive domains. Normal aging is characterized by cognitive deficits that may worsen the production capacity and quality of life. Such deficits represent variations of normal , and may stabilize,or even better progress. Include multiple cognitive domains, such as working and episodic memory, and attention. Despite the heterogeneity of the nature and severity of these deficits, common characteristics were observed in neuropsychological assessment of that population, for example, reduction in processing speed. There is an important gap in the therapeutic approach of these individuals.
Transcranial magnetic stimulation (TMS) is a noninvasive and promising intervention, with potential to improve memory and cognition activating networks that operate on memory or other networks that interfere with cognitive performance. The technique relies on generating a variable magnetic field originated from an alternating electric current applied to the human skull reaching focal cortical regions.
This study is a sham-controlled clinical trial, randomized, double-blind study. It will be evaluated the effects of repetitive transcranial magnetic stimulation (rTMS) on global cognition (memory, attention, language, executive functions, planning, logical reasoning, calculation and visual-spatial perception), especially memory, of elderly individuals with mild cognitive impairment, included in the domain of cognitive impairment no dementia (CIND).
Detailed description
Subjects:
- Eligibility criteria:
- Male and female participants
- Older adults aged 60-74 years
- Education ≥ 4 years
- Performance on neuropsychological tests below normal for age and education
- Availability to attend the sessions of the application of TMS and neuropsychological assessments
- Signing an informed consent by the participant or his guardian
II. No eligibility criteria:
- Prior diagnosis of dementia
- Any psychiatric disorder, except for mild depression in remission for at least 6 months. Shall be excluded those with scores > 12 on the Hamilton Depression Scale
- History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery
- Clinical or neurological diseases with impact on cognitive ability
- Neurodegenerative central nervous system disease(eg. Parkinson Disease)
- Alcohol and other drug abstinence for less than one year
- Use of psychotropic medications (anticholinergic, mood stabilizers, neuroleptics), except for antidepressants
- Chronic use of benzodiazepines with abstinence for less than 6 months
- Severe uncontrolled organic disease that might interfere with the conduct of the study, such as cancer, congestive heart disease, digestive disorders, diabetes mellitus type I or type II, dyslipidemia etc.
- Sensory impairments(to guarantee a adequate performance in the tests to evaluate cognitive functions)
- Magnetic resonance imaging of the brain with evidence of lacunar or large vessels infarctions, cerebral hemorrhage
- Hachinski Ischemic score of > 7 (or modified by Loeb > 5) 14. Any other condition that in the opinion of the investigator becomes problematic inclusion of the patient in a trial of this nature, as well as patients who do not adhere or do not cooperate.
III. Outcome measures:
Will be considered as an outcome measure a variation greater than or equal to 10% compared to baseline scores of neuropsychological tests, which will be applied on three occasions: immediately before (T0), after treatment (T2) and 4 weeks after the end of it (T3).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS versus Sham | Sham comparator | Device: Repetitive transcranial magnetic stimulationrTMS: active coil Sham: inactive coil |
| rTMS versus sham | Active comparator | Device: Repetitive transcranial magnetic stimulationrTMS group: active coil Sham group: inactive coil |
Who may qualify
- Ages
- 60 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants of both sexes
- Aged between 60 and 74 years
- Schooling ≥ 4 years
- Performance on neuropsychological tests of up to 1.5 standard deviations below normal for age and education
- Signing an informed consent by the participant or his guardian.
Key exclusion criteria (16 listed)
- Prior diagnosis of dementia.
- Any psychiatric disorder, except for mild depression for at least six months.
- Shall be excluded those with scores> 12 on the Hamilton scale.
- History of neurosurgery and implantation of metal clips, head trauma, implantation of cardiac pacemakers, stroke, transient ischemic attack, cardiac surgery
- Clinical or neurological diseases with an impact on cognitive ability
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulationAlso: Active rTMS group, Sham rTMS groupIntensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 trains Duration of trains: 5 seconds Interval: 25 seconds Number of sessions: 10 sessions Duration of intervention: two consecutive weeks | Device | rTMS versus Sham, rTMS versus sham |
| Repetitive transcranial magnetic stimulationAlso: Arm 1: Active rTMS, Arm 2: Sham rTMSIntensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 Duration of trains: 5 seconds Interval inter trains: 25 seconds Number of pulses each session: 2.000 Total number of pulses: 20.000 | Device | rTMS versus Sham, rTMS versus sham |
Primary outcome
Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints
Time frame: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Neuropsychological tests - RBMT (Rivermead Behavioral and Memory Test)
1 secondary outcome
Repetitive transcranial magnetic stimulation improves global cognition of elderly with memory complaints
Time frame: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2011.
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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.
Marco Marcolin principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation in people with Mild Cognitive Impairment, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 5 inclusion and 16 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 21 Apr 2011. 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 Brazil. 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?
Contact Hellen Marra (55 11 3069-8159, hellen.marra@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repetitive transcranial magnetic stimulation improves memory in elderly with memory complaints (time frame: Neuropsychological tests: T1 - effects after rTMS, and T2: 4 weeks after rTMS). 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 21 Apr 2011.