Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03665831|
Recruitment Status : Recruiting
First Posted : September 11, 2018
Last Update Posted : October 1, 2019
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Alzheimer Disease Mild Cognitive Impairment||Device: Brainsway H1-Coil Deep TMS System||Not Applicable|
This study is an open-label trial to evaluate the safety and efficacy of H1-coil dTMS in treating depression in MCI and mild AD patients over 60 years of age who have not tolerated or failed to respond to antidepressant medications. 28 patients will be assigned to receive 4 consecutive weeks of daily active dTMS treatment. The long-term effects of treatment on emotional cognitive measures will be assessed at a 4-week follow-up visit (8 weeks from baseline). Symptom change and remission criteria will be assessed using the Montogmery-Asberg Depression Rating Scale (MADRS). Cognition will be assessed using a validated neuropsychological battery.
We will also offer patients to receive 4 weeks of treatment using theta-burst TMS, which is a milder version of TMS.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||28 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)|
|Actual Study Start Date :||October 23, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||April 2020|
|Experimental: Active H1 Coil deep rTMS active treatment||
Device: Brainsway H1-Coil Deep TMS System
Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered daily for 4 consecutive weeks.
- Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 4 weeks ]Therapeutic efficacy will be evaluated with the MADRS, a 10-item checklist. An effect size (Cohen's d) of 0.5 will be considered a minimally important effect size.
- Remission Rates Compared Within Treatment Group [ Time Frame: 4 weeks ]Remission defined as MADRS < 10.
- Response Rates Compared Within Treatment Group [ Time Frame: 4 weeks ]Response rate refers to the percentage of patients who responded to dTMS treatment and response is defined as a ≥50% reduction in MADRS score from baseline.
- Change From Baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) [ Time Frame: 4 weeks ]This 16-item questionnaire is designed to help assess the degree of enjoyment and satisfaction experienced during the past week. Administration time is approximately 5 minutes.
- Change From Baseline on the Neuropsychological Battery [ Time Frame: 4 weeks ]Cognitive scores from the neuropsychological battery at baseline will be compared to 4 weeks post-intervention Cognitive domains tested include executive function, memory, language, attention, and intelligence.
- Change in Functional Connectivity between PFC and Limbic Regions [ Time Frame: 4 weeks ]Subjects will have magnetic resonance imaging (MRI) scans of the brain. The change in functional connectivity between PFC and limbic regions, and within the default mode network, at rest is measured using resting state fMRI.
- Change in Perfusion within Prefrontal Cortex (PFC) and Posterior Cingulate Cortex (PCC) [ Time Frame: 4 weeks ]Measured using Arterial Spin Labeling (ASL) fMRI scan.
- Change in frontal theta power within the Anterior Cingulate Cortex (ACC) [ Time Frame: 4 weeks ]Measured with electroencephalography (EEG) and/or magnetoencephalography (MEG).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03665831
|Contact: Christina Deonarain, MSc||416-785-2500 ext firstname.lastname@example.org|
|Contact: Linda Mah, MD||416-785-2500 ext email@example.com|
|Rotman Research Institute at Baycrest||Recruiting|
|Toronto, Ontario, Canada, M6A 2E1|
|Contact: Linda Mah, MD, MHS, FRCPC 416-785-2500 ext 3365 firstname.lastname@example.org|