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New treatment option for Old Age
Official title Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
ClinicalTrials.gov ID: NCT04783103
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 and older
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- Any change in the habitual psychopharmacological agents will be considered as dropout.
See the full eligibility 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.
- 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...
- 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...
- Any change in the habitual psychopharmacological agents will be considered as dropout.
The study team makes the final eligibility decision.
Where it's taking place
- Jette, Brussels Capital, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jette, Brussels Capital, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.