Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
NCT04783103

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

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

UZ Brussel

Jette, Brussels Capital, Belgium, 1090

Actively Recruiting

Loading map...

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

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

Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study | DecenTrialz