- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665831
Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
Treatment of Comorbid Depression and Cognitive Impairment in Older Adults With Neurocognitive Disorders Using Deep Transcranial Magnetic Stimulation (dTMS)
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amanda Rahmadian, BSc
- Phone Number: 3434 416-785-2500
- Email: dtms@research.baycrest.org
Study Contact Backup
- Name: Linda Mah, MD
- Phone Number: 3365 416-785-2500
- Email: lmah@research.baycrest.org
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M6A 2E1
- Recruiting
- Rotman Research Institute at Baycrest
-
Contact:
- Linda Mah, MD, MHS, FRCPC
- Phone Number: 3365 416-785-2500
- Email: lmah@research.baycrest.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- meet DSM 5 criteria for Major or Mild Neurocognitive Disorder due to Alzheimer's disease with Clinical Dementia Rating Scale (CDR) score of at least 0.5
- have been diagnosed with DSM5 Major Depressive Disorder, with the current episode longer than 4 weeks but less than 5 years
- did not respond to or did not tolerate antidepressant treatment
- are willing to provide informed consent
- are able to follow the treatment schedule
- are stable on medications for 2 months and are not expected to change medication during the entire study period (if they are taking medications)
- have a satisfactory safety screening questionnaire for TMS
- have an informant/study partner who is able to complete study questionnaires regarding the participant
Exclusion Criteria:
- have a metal plate in their head, except in the mouth (such as an ear implant, implanted brain stimulators, aneurysm clips)
- have known increased pressure or a history of increased pressure in their brain, which may increase their risk for having seizures
- have a cardiac pacemaker
- have an implanted medication pump
- have a central venous line
- have a significant heart disease or history of stroke
- Modified Hachinski Score (MHIS) > 3 (to exclude those with significant vascular component to memory loss)
- have a history of any psychotic disorder, bipolar disorder, eating disorder, obsessive compulsive disorder, post-traumatic stress disorder, or dementia other than AD
- have a history of substance abuse in the last 6 months
- have a history of stroke or other brain lesions
- have a personal history of epilepsy
- have a family history of epilepsy
- are a pregnant or breast-feeding woman
- are taking psychotropic medications including antidepressant medications, antipsychotics or mood stabilizing medications due to increased risk of seizure
- are taking memantine
- have a history of abnormal MRI of the brain
- have significant hearing loss requiring use of hearing aids
- have untreated hypo- or hyper-thyroidism
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active H1 Coil deep rTMS active treatment
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Remission Rates Compared Within Treatment Group
Time Frame: 4 weeks
|
Remission defined as MADRS < 10.
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
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.
|
4 weeks
|
Change in Perfusion within Prefrontal Cortex (PFC) and Posterior Cingulate Cortex (PCC)
Time Frame: 4 weeks
|
Measured using Arterial Spin Labeling (ASL) fMRI scan.
|
4 weeks
|
Change in frontal theta power within the Anterior Cingulate Cortex (ACC)
Time Frame: 4 weeks
|
Measured with electroencephalography (EEG) and/or magnetoencephalography (MEG).
|
4 weeks
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Dementia
- Tauopathies
- Cognition Disorders
- Depression
- Depressive Disorder
- Alzheimer Disease
- Cognitive Dysfunction
- Depressive Disorder, Major
Other Study ID Numbers
- CICP-2-00095
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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