Enhancing Working Memory in Patients With Early Alzheimer's Disease Through the Use of rTMS
NCT ID: NCT02537496
Last Updated: 2019-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
36 participants
INTERVENTIONAL
2016-01-14
2018-10-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
TMS in Preclinical and Prodromal AD: Modulation of Brain Networks and Memory
NCT04294888
Deep Repetitive Transcranial Magnetic Stimulation (rTMS) of the Precuneus for Alzheimer Disease (AD)
NCT06597942
Study of Repetitive Transcranial Magnetic Stimulation (rTMS) as add-on Treatment for Early Alzheimer's Disease
NCT01481961
Network-guided TMS in Early Alzheimer's Disease
NCT04549155
Deep Transcranial Magnetic Stimulation in Patients With Alzheimer's Disease
NCT00753662
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Hypothesis 1a: Compared to healthy individuals, participants with AD will be impaired on the N-back task.
Hypothesis 1b: Compared to sham rTMS, active rTMS will result in improvement on the N-back task in participants with AD at 1 week and 4 weeks after the treatment.
Specific aim 2: To assess DLPFC theta-gamma coupling during working memory performance in AD and its change in response to a 4-week course of bilateral rTMS of DLPFC.
Hypothesis 2a: Compared to healthy individuals, participants with AD will be impaired on DLPFC theta-gamma coupling during the N-back task.
Hypothesis 2b \& 2c: Compared to sham rTMS, active rTMS will result in improvement in DLPFC theta-gamma coupling during the N-back task in participants with AD at 1 week and 4 weeks after the treatment.
Specific aim 3: To assess DLPFC neuroplasticity using PAS in participants with AD and its change in response to a 4-week course of bilateral rTMS.
Hypothesis 3a: Compared to healthy individuals, participants with AD will be impaired on PAS-induced neuroplasticity.
Hypothesis 3b: Compared to sham rTMS, active rTMS will result in improvement on PAS-induced neuroplasticity in participants with AD at 1 week and 4 weeks after the treatment.
Specific aim 4: To assess change in working memory, theta gamma coupling and DLPFC neuroplasticity at 6 months after the course of bilateral rTMS.
Hypothesis 4: Compared to sham rTMS, active rTMS group will perform better on measures of working memory, theta gamma coupling and PAS- induced DLPFC neuroplasticity 6 months after the course of rTMS.
Specific aim 5: To assess the change in general cognitive function at 4 weeks and 6 months after the course of bilateral rTMS.
Hypothesis 5: Compared to sham rTMS, active rTMS group will perform better on measures of general cognitive function at 4 weeks and 6 months after the course of rTMS.
Specific Aim 6: To assess insight in AD at baseline and any change in insight at 4 week and 6 month post rTMS follow up. H6: Participants with AD will have impaired insight into illness and cognitive function and they will experience improved insight at 4 week and 6 month follow up points.
Specific Aim 7: To validate a new scale for insight in AD , 'The Scale to Assess Anosognosia in Neurocognitive Disorders' (SAND) for its ability to assess insight at baseline and any change at 4 weeks and 6 month follow up points. H7: In participants with AD, SAND will be able to assess insight into illness and cognitive function at baseline, and will be able to detect change in insight at follow up points.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Alzheimer's disease rTMS
The intervention procedure done in this group is repetitive Transcranial Magnetic Stimulation.
Repetitive Transcranial Magnetic Stimulation
Active treatment will be delivered at 90% resting motor threshold intensity. Stimulation will be administered at 20 Hz with 25 stimulation trains of 30 stimuli each with an inter-train interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right DLPFC.
Alzheimer's disease rTMS Sham
The intervention procedure done in this group is Repetitive Transcranial Magnetic Stimulation - Sham
Repetitive Transcranial Magnetic Stimulation - Sham
Same stimulation parameters and site as active condition will be used, but with placebo coil which will have minimal direct brain effects
Healthy Control
Healthy control group will only participate in baseline assessments which include baseline neuropsychological testing and baseline measurement of neuroplasticity. This will be used to standardize neuropsychological test scores and to compare the baseline neuroplasticity between healthy participants and Alzheimer's disease (AD) participants. Healthy control group will not get rTMS intervention.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Repetitive Transcranial Magnetic Stimulation
Active treatment will be delivered at 90% resting motor threshold intensity. Stimulation will be administered at 20 Hz with 25 stimulation trains of 30 stimuli each with an inter-train interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right DLPFC.
Repetitive Transcranial Magnetic Stimulation - Sham
Same stimulation parameters and site as active condition will be used, but with placebo coil which will have minimal direct brain effects
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Ability to understand and speak English.
3. Confirmed Diagnosis of Probable AD by NIA-AA criteria.
4. Either not taking Cognitive enhancers or taking them at a stable dose for the last 3 months.
5. Willingness and ability to provide informed consent or an ability to assent and availability of a substitute decision maker willing to provide consent on participant's behalf.
6. Corrected visual acuity enough to read newspaper headlines.
7. Ability to hear a raised conversational voice, with hearing aids if needed.
1. Age 55 or above.
2. Willingness and ability to speak English.
3. Willingness and ability to provide informed consent.
4. Corrected visual acuity enough to read newspaper headlines.
5. Ability to hear a raised conversational voice, with hearing aids if needed.
Exclusion Criteria
2. DSM IV - TR diagnosis of a current episode of mood disorder in the last 3 months.
3. DSM IV - TR diagnosis of a current anxiety disorder in the last 3 months.
4. DSM IV - TR diagnosis of a current substance use disorder in the last 3 months.
5. DSM IV - TR diagnosis of a current or lifetime primary psychotic disorder.
6. Diagnosis of intellectual disability or a neurodevelopmental disorder.
7. Electroconvulsive Therapy treatment in the last 6 months.
8. History of a seizure other than a febrile seizure in infancy.
9. Currently taking Anticonvulsants or Benzodiazepines.
10. Any contraindication for TMS or any other medical condition/circumstances that would make the study participation difficult for the participant.
1. Meets criteria for a DSM IV - TR diagnosis other than simple phobias or Adjustment disorder.
2. Any other neurological disorder affecting central nervous system.
3. Psychotropic medication except for sedative /hypnotics at a stable dose for at least 4 weeks.
4. History of seizure other than a febrile seizure in infancy
5. Currently taking Anticonvulsants or Benzodiazepines.
6. Any contraindication for TMS or any other medical condition/circumstances that would make the study participation difficult for the participant.
55 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brain & Behavior Research Foundation
OTHER
University of Toronto
OTHER
Centre for Addiction and Mental Health
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sanjeev Kumar
Sanjeev Kumar, MD, FRCPC
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sanjeev Kumar, MD, FRCPC
Role: PRINCIPAL_INVESTIGATOR
Center for Addiction and Mental Health
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Center for Addiction and Mental Health
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
Description: The Centre for Addiction and Mental Health (CAMH) is the leading mental health and addictions research facility in Canada, and one of the largest in the world.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
005/2015
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.