Actively Recruiting
Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
Led by Universitair Ziekenhuis Brussel · Updated on 2022-11-03
44
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of an accelerated deep brain Transcranial Magnetic Stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) in older adults with depression. This study focuses on geriatric depression, a growing health concern with serious impacts, and explores non-drug treatments to reduce risks associated with multiple medications and side effects. The trial includes brain imaging and examines the gut microbiome to better understand how these treatments work and affect patients biologically. Participants will be randomly assigned to receive either real adTMS or a sham (placebo) version, with 20 sessions delivered over four consecutive days (five sessions daily). One week after this initial treatment phase, all participants will have access to active tDCS therapy for three weeks using a home-use device. This design allows researchers to compare the effects of tDCS following either active or sham adTMS and to study the potential maintenance effects of tDCS after adTMS. During the study, participants will undergo several evaluations including clinical assessments of depression severity, cognitive tests, and safety monitoring at specified intervals. Brain imaging will be performed to observe changes related to emotional processing and limbic function, and stool samples will be collected to study changes in the gut microbiome. The primary outcome is the change in depression severity measured at screening, day 1, day 8, day 15, and day 36. Safety and other secondary effects will also be closely monitored throughout the study period, which lasts over a month from the first treatment day.
CONDITIONS
Brief Title
Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 65 years or older
- Diagnosed with unipolar depression according to DSM 5
- Hamilton Depression Rating Scale (HDRS-17) score of 17 or higher
- Failed to respond to at least one adequate antidepressant medication trial, including the current one
- On a stable antidepressant treatment for more than 6 weeks
- Benzodiazepine use allowed up to 40 mg diazepam or equivalent if stable for at least 2 weeks
- Able to read, understand, and sign informed consent
You will not qualify if you...
- Psychosis except depression with psychotic features
- Personal or first-degree family history of seizures or epilepsy
- Factors that lower seizure threshold (e.g., sleep deprivation, substance abuse)
- Previous head injury or metallic implants in the head region (except dental fillings)
- Presence of cardiac pacemakers, neurostimulators, or other electronic implants
- Neurological disorders such as increased intracranial pressure, brain lesions, stroke, or aneurysm
- Cognitive impairment or dementia with Mini Mental State Examination score below 24
- Suicide attempt within 6 months or high suicide risk per clinical judgment and rating scales
- Any change in usual psychopharmacological treatment during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 days
Participants receive 20 sessions of real or sham accelerated deep TMS over 4 consecutive days, with 5 sessions per day.
Daily visits for 4 consecutive days (5 sessions per day)
Duration - 3 weeks
One week after the adTMS or sham treatment, participants use a home device for transcutaneous direct current stimulation for 3 weeks.
Home use of device daily for 3 weeks
Duration - Up to approximately 5 weeks after treatment start
Participants have follow-up assessments to evaluate clinical efficacy, safety, neuroimaging, cognitive function, suicide risk, and gut microbiome effects.
Visits on Day 8, Day 15, and Day 36 post-treatment start
Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
D
Dieter Zeeuws, MD
C
Chris Baeken, MD Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here