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Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

ConditionsMajor Depressive DisorderAlzheimer DiseaseMild Cognitive Impairment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorRotman Research Institute at Baycrest

About this trial

In this study, the investigators will be examining the effects of the deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil in patients over the age of 60 diagnosed with mild to early-moderate Alzheimer's disease (AD) or mild cognitive impairment (MCI) and comorbid Major Depressive Disorder (MDD) who have been unable to tolerate or failed to respond to antidepressant medications. The coil was designed to stimulate deeper regions of the left dorsolateral prefrontal cortex (DLPFC). Based on prior research, the investigators propose that active stimulation with the H1 coil for 4 weeks may result in significant remission rates and will be tolerable and safe.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Brainsway H1-Coil Deep TMS System

    Device

    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.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Active H1 Coil deep rTMS active treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)

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.

Time frame
4 weeks

Secondary outcomes

1

Remission Rates Compared Within Treatment Group

Remission defined as MADRS \< 10.

Time frame
4 weeks
2

Response Rates Compared Within Treatment Group

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.

Time frame
4 weeks
3

Change From Baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)

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.

Time frame
4 weeks
4

Change From Baseline on the Neuropsychological Battery

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.

Time frame
4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rotman Research Institute at Baycrest

Lead sponsor

Brainsway

Collaborator

Centre for Addiction and Mental Health

Collaborator

Source ClinicalTrials.gov
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