Deep rTMS for Depression in Older Adults

NCT05855850 | Completed

• 1 other identifier: 15344
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to: (1) assess the feasibility and tolerability of two active dTMS coils - H4 and H7 - in older adults with depression; and (2) clinical response measured by change from baseline on the Hamilton Depression Rating Scale- 24 item; changes in cognitive function through neuropsychological assessment; and changes in regional electrophysiological activity and functional connectivity indexed by EEG. Through a parallel design, participants will complete a four-week course of five dTMS sessions per week, for a total of 20 stimulation sessions. Participants will be randomly assigned to either coil (H4 or H7) and will complete questionnaires examining side effects, mental health symptoms, and cognition. Participant EEG data will be measured and collected at baseline and at the end of each week. Collectively, the study will address the absolute and differential feasibility and tolerability of the two active coils to provide preliminary data for a future randomized controlled trial comparing one or both of these novel interventions to the established H1-coil and a sham stimulation (placebo) control.

Conditions

Major Depressive Disorder

Keywords

Major Depressive Disorder; MDD; depressive disorder; depression; late-life depression; mood disorders; deep transcranial magnetic stimulation; deep TMS; dTMS; H coil; H-coil; older adults; H4-coil; H7-coil

Outcome Measures

Primary Outcomes (7)

• Feasibility criteria 1: Protocol completion

  Percentage of intervention sessions completed

  4 weeks

• Feasibility criteria 2: Retention rate

  Percentage of participants who complete study once enrolled

  4 weeks

• Feasibility criteria 3: Screening rates and capacity

  Number of participants (n) screened; n enrolled as a percentage of n screened monthly

  4 weeks

• Feasibility criteria 4: Recruitment rate and capacity

  Total number of participants recruited and enrolled per month.

  4 weeks

• Feasibility criteria 5: Duration of intervention and assessment processes

  Compared to estimated times, the actual mean times (in min) from start to finish for each dTMS intervention session and mean time (in hours) from start to finish for each visit.

  4 weeks

• Feasibility criteria 5: Safety of H-coil dTMS treatment

  Total number of adverse events reported during the treatment sessions assessed by the Side Effects Questionnaire for dTMS (custom-developed for study). At each dTMS stimulation session, participants will complete a questionnaire to evaluate potential adverse effects of dTMS (headache, neck pain, itching and redness at the site of stimulation) according to a 4-point scale.

  4 weeks

• Tolerability of H-coil dTMS treatment

  Percentage of participants withdrawn or terminated following enrollment due to adverse events

  4 weeks

Secondary Outcomes (7)

• Change from baseline on the Hamilton Depression Rating Scale- 24 item (HDRS-24).

  4-weeks + 2-week follow-up

• Changes from baseline on the Geriatric Depression 30-item Scale (GDS-30)

  4-weeks + 2-week follow-up

• Change from baseline on the General Anxiety Disorder- 7 item (GAD-7)

  4-weeks + 2-week follow-up

• Change from baseline on the Pittsburgh Sleeping Quality Index (PSQI)

  4-weeks + 2-week follow-up

• Change from baseline on the Patient Health Questionnaire (PHQ - Somatic Symptoms)

  4-weeks + 2-week follow-up

Study Arms (2)

Active H4-coil dTMS treatment

EXPERIMENTAL

Device: Brainsway H4-Coil Deep TMS System

Active H7-coil dTMS treatment

EXPERIMENTAL

Device: Brainsway H7-Coil Deep TMS System

Interventions

Brainsway H4-Coil Deep TMS System DEVICE

Participants assigned to this arm will complete a 4-week course of 5 dTMS sessions per week (using the Brainsway H4-coil), for a total of 20 stimulation sessions. We will follow the standard Health Canada and FDA-approved protocol for depression: 18 Hz and 55 trains, for a total of 1980 pulses.

Active H4-coil dTMS treatment

Brainsway H7-Coil Deep TMS System DEVICE

Participants assigned to this arm will complete a 4-week course of 5 dTMS sessions per week (using the Brainsway H7-coil), for a total of 20 stimulation sessions. We will follow the standard Health Canada and FDA-approved protocol for depression: 18 Hz and 55 trains, for a total of 1980 pulses.

Active H7-coil dTMS treatment

Eligibility Criteria

• Age: 60 Years - 85 Years
• Gender Eligibility Details: We will implement a sex equity approach by aiming at a 50/50% rate of male and female but allowing an imbalance of maximum 60/40% from either side.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A) 60 - 85 years old
• B) Able to provide informed consent to participate in the study
• C) MDD diagnosis, single or recurrent episode, assessed using Evaluation of the Diagnostic Assessment Research Tool (DART) Screener for DSM-5 Mood Disorder Module
• D) Total score of at least 20 on the 24-item Hamilton Depression Rating Scale (HDRS-24) at screening visit
• E) Treatment resistance to antidepressant pharmacotherapy during the current episode as indexed by Antidepressant Treatment History Form - Short Form (ATHF - SF). Specifically, participants will be required to have failed at least one or to have had an inadequate trial (including intolerance) to at least two antidepressants in the current episode
• F) Participants will be required to be on stable dosages of other psychotropic medications for at least 4 weeks prior to screening

You may not qualify if:

• A) Primary diagnosis of bipolar I or II disorder; psychotic disorder; obsessive-compulsive, post-traumatic stress, anxiety, or personality disorder; participants with anxiety or personality disorders will be eligible if is not their primary diagnosis
• B) Active suicidal behavior
• C) Substance dependence/abuse in the past 3 months before entering the study (this will be screened via self-report and verified by urine screening test)
• D) Possible dementia diagnosis based on a Mini Mental Status Exam (MMSE) score of \<24 and clinical presentation of dementia
• E) Unsuccessful ECT treatment on the current episode
• F) Traditional contraindications to rTMS: Intracranial or metal implants in the head or nearby regions, excluding the mouth, that cannot be safely removed; History of epilepsy or seizures; Active unstable medical condition (recent laboratory and neuroimaging alterations); Pacemaker and/or implantable cardioverter-defibrillators; current use of bupropion \>300 mg/day as it is associated with risk of seizures, treatment with equivalent benzodiazepine dose to lorazepam \>2 mg/day
• G) People with severe literacy, visual, or hearing issues that affect their ability to engage in the interviews
• H) People with recurring migraines or headaches (weekly or more).
• I) Individuals residing beyond the borders of the Greater Hamilton Area and its neighbouring vicinities.

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead
• Peter Boris Centre for Addictions Research (PBCAR): collaborator

Study Sites (1)

Peter Boris Centre for Addictions Research, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L9C 0E3, Canada

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder; Depression; Mood Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Dante Duarte, MD, MSc, PhD

  Peter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

  PRINCIPAL INVESTIGATOR

• James MacKillop, PhD

  Peter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

  STUDY DIRECTOR

• Emily MacKillop, PhD, ABPP-CN

  Peter Boris Centre for Addictions Research at St. Joseph's Healthcare, Hamilton

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This is an open label trial. Only study staff processing and analyzing the data will be fully blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This investigation is a one-way two-group between-subjects open-label design

Study Record Dates

• First Submitted: February 6, 2023
• First Posted: May 12, 2023
• Study Start: April 18, 2023
• Primary Completion: June 3, 2024
• Study Completion: June 3, 2024
• Last Updated: June 17, 2024

Record last verified: 2024-06

Locations

CA (1)