Neuromodulation treatment for elderly patients with depression
Neuromodulation in the Elderly Depressed: a Brain Im-aging Pilot Study
This study is testing a new brain treatment for older adults with depression who haven't found relief from other medications to see if it can help them feel better without the side effects of pills.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Universitair Ziekenhuis Brussel Academic / other |
| Locations | 1 site (Jette, Brussels Capital) |
| Trial ID | NCT04783103 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of an accelerated deep brain Transcranial Magnetic Stimulation (adTMS) and transcutaneous direct current stimulation (tDCS) protocol in elderly patients suffering from treatment-resistant depression. It aims to address the growing issue of geriatric depression by utilizing non-pharmaceutical treatments that minimize the risk of side effects associated with polypharmacy. The trial will involve 44 participants who will receive either active or sham treatment, followed by access to tDCS, allowing researchers to assess both immediate and maintenance effects of the interventions. Multimodal brain imaging techniques will be employed to better understand the neurobiological impacts of these treatments.
Who should consider this trial
Good fit: Ideal candidates are elderly individuals aged 65 and older who have been diagnosed with unipolar depression and have not responded to previous antidepressant treatments.
Not a fit: Patients with psychosis or a personal history of seizures or epilepsy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel, effective treatment option for elderly patients with treatment-resistant depression.
How similar studies have performed: Previous studies have shown promising results with similar neuromodulation techniques, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • In- and outpatients (age 65 year or older). * Meeting the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) criteria for unipolar depression according 17-item Hamilton depression rating scale (HDRS-17) score of 17 or more. * Failed to respond to at least one adequate course with an antidepressant medication trial, including the current one. * Intention to continue the current (\>6 weeks) antidepressant treatment at a stable dose dur-ing the stimulation. * Benzodiazepines are permitted up to a maximum dose of 40 mg diazepam or equivalent. If the dosage has been recently changed, it should be stable for at least 2 weeks. * Able to read, understand and sign the Informed Consent Form. Exclusion Criteria: * • Psychosis (except depression with psychotic features). * A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold (sleep deprivation, substance abuse, etc.), previous head injury and the presence of metallic implants in the cephalic region (e.g., aneurysm clips, shunts, stimulators, cochlear implants, electrodes) with the exception of dental fillings. The presence of cardiac pacemakers, neurostimulators, surgical clips or other electronic equipment, comorbidity with the following neurological disorders: increased intracranial pressure, space-occupying lesion, history of stroke or transient ischemic attack, brain aneurysm and any structural brain damage with increased risk for epilepsy detected with (study related) MRI. * Patients with cognitive disturbances or dementia (Mini Mental State) \< 24. * Suicide attempt within 6 months before the start of the study or present high risk of suicide per the investigator's clinical judgment and indicative response\* on the Columbia-Suicide Severity Rating Scale (C-SSRS) and 21-items Beck Scale for Suicide Ideation (BSI). \*'yes' on Item 5 (active suicidal ideation with specific plan and intent). * Any change in the habitual psychopharmacological agents will be considered as dropout.
Where this trial is running
Jette, Brussels Capital
- UZ Brussel — Jette, Brussels Capital, Belgium (Recruiting)
Study contacts
- Principal investigator: Dieter Zeeuws, MD — Universitair Ziekenhuis Brussel
- Study coordinator: Dieter Zeeuws, MD
- Email: dieter.zeeuws@uzbrussel.be
- Phone: +324763459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.