Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults

NCT03665831 | Recruiting FDA Device

• 1 other identifier: CICP-2-00095
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder; Alzheimer Disease; Mild Cognitive Impairment

Keywords

dTMS; depression; magnetic; iTBS

Outcome Measures

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.

  4 weeks

Secondary Outcomes (7)

• Remission Rates Compared Within Treatment Group

  4 weeks

• Response Rates Compared Within Treatment Group

  4 weeks

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

  4 weeks

• Change From Baseline on the Neuropsychological Battery

  4 weeks

• Change in Functional Connectivity between PFC and Limbic Regions

  4 weeks

Study Arms (1)

Active H1 Coil deep rTMS active treatment

EXPERIMENTAL

Device: Brainsway H1-Coil Deep TMS System

Interventions

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.

Active H1 Coil deep rTMS active treatment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rotman Research Institute at Baycrest: lead
• Brainsway: collaborator
• Centre for Addiction and Mental Health: collaborator

Study Sites (1)

Rotman Research Institute at Baycrest

Toronto, Ontario, M6A 2E1, Canada

RECRUITING

Related Publications (1)

• Hodzic-Santor BH, Meltzer JA, Verhoeff NPLG, Blumberger DM, Mah L. Safety, tolerability, and feasibility of deep transcranial magnetic stimulation for late-life depression with comorbid major or mild neurocognitive disorder. Int Psychogeriatr. 2021 Jan;33(1):99-101. doi: 10.1017/S1041610220003543. Epub 2020 Nov 6. No abstract available.

  PMID: 33153503 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Alzheimer Disease; Cognitive Dysfunction; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Cognition Disorders; Behavioral Symptoms; Behavior

Central Study Contacts

Amanda Rahmadian, BSc

CONTACT

416-785-2500; dtms@research.baycrest.org

Linda Mah, MD

CONTACT

416-785-2500; preventad@research.baycrest.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist

Study Record Dates

• First Submitted: September 7, 2018
• First Posted: September 11, 2018
• Study Start: October 23, 2018
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): September 15, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-04

Locations

CA (1)