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
268 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To evaluate safety and efficacy of an accelerated deep brain Transcranial Magnetic stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) protocol in an elderly depressed patient population
CONDITIONS
Official Title
Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 65 years or older (inpatients or outpatients)
- Diagnosed with unipolar depression meeting DSM 5 criteria with HDRS-17 score of 17 or higher
- Failed to respond to at least one adequate antidepressant treatment including the current one
- Intend to continue stable antidepressant treatment for more than 6 weeks during stimulation
- Benzodiazepine use allowed up to 40 mg diazepam or equivalent with stable dose for at least 2 weeks if recently changed
- Able to read, understand, and sign the informed consent form
You will not qualify if you...
- Presence of psychosis except depression with psychotic features
- Personal or family history of seizures or epilepsy or factors lowering seizure threshold (e.g., sleep deprivation, substance abuse)
- Previous head injury or metallic implants in the head except dental fillings
- Presence of cardiac pacemakers, neurostimulators, surgical clips, or other electronic devices
- Neurological disorders including increased intracranial pressure, brain lesions, stroke, aneurysm, or structural brain damage with epilepsy risk
- Cognitive impairment or dementia with Mini Mental State score below 24
- Suicide attempt within 6 months or high suicide risk per clinical judgment and specific rating scales
- Any change in regular psychopharmacological medications during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
UZ Brussel
Jette, Brussels Capital, Belgium, 1090
Actively Recruiting
Research Team
D
Dieter Zeeuws, MD
CONTACT
C
Chris Baeken, MD Phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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