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Deep TMS for Depression and Cognitive Impairment in Older Adults

N/A
Recruiting
Research Sponsored by Rotman Research Institute at Baycrest
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Did not respond to or did not tolerate antidepressant treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will test if an electrical brain stimulation called rTMS with an H1 coil can help people over 60 with Alzheimer's/MCI and depression who haven't responded to antidepressants. It's proposed that 4 weeks of stimulation may reduce depression and be safe.

Who is the study for?
This trial is for people over 60 with mild to early-moderate Alzheimer's or cognitive impairment and depression, who haven't done well with antidepressants. They must be stable on current meds, able to consent and follow the schedule, have a partner to help with questionnaires, and pass a safety screening for TMS.Check my eligibility
What is being tested?
The study tests deep repetitive transcranial magnetic stimulation (rTMS) using the H1 coil on deeper brain regions in older adults. It aims to see if this treatment can safely improve depression symptoms without changing other medications.See study design
What are the potential side effects?
While not explicitly listed in your information provided, common side effects of rTMS may include headache, scalp discomfort at the site of stimulation, tingling or spasms of facial muscles.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with Alzheimer's affecting my thinking or memory, with a mild to moderate impact.
Select...
Antidepressants didn't work for me or caused side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change From Baseline on the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcome measures
Change From Baseline on the Neuropsychological Battery
Change From Baseline on the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Limbic System
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Active H1 Coil deep rTMS active treatmentExperimental Treatment1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brainsway H1-Coil Deep TMS System
2013
N/A
~60

Find a Location

Who is running the clinical trial?

BrainswayIndustry Sponsor
37 Previous Clinical Trials
2,724 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
356 Previous Clinical Trials
81,430 Total Patients Enrolled
Rotman Research Institute at BaycrestLead Sponsor
10 Previous Clinical Trials
434 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults
Linda Mah, MD 2018. "Deep TMS for Comorbid Depression and Cognitive Impairment in Older Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03665831.
All > Alzheimer Disease > Alzheimers Disease
~1 spots leftby Aug 2024
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