Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study

NCT04783103 | Recruiting

• 1 other identifier: 2020/324
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Old Age; Depressive Disorder, Treatment-Resistant

Outcome Measures

Primary Outcomes (1)

• Clinical effect of adTMS (Changes in depression severity clinician-rated and self-report)

  To investigate the effect of adTMS delivered by a H1 coil to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD.-measured by change in the 17 item Hamilton Depression rating Scale score. For a total score between 0 and 48, the higher the total score the more severe the depression. Response is reduction from baseline of ≥ 50% in the total score and remission is a total HAMD-17 score ≤ 7. * measured by change in the Beck-Inventory of Depression-II score. For a total score between 0 and 63, the higher the total score the more severe the depression. A score of ≤9 is the criterion for remission and BDI-II score decrease of 50% from baseline is the criterion for treatment response. * measured by change in the Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score.

  screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)

Secondary Outcomes (12)

• Clinical effect of tDCS 17 item Hamilton Depression rating Scale score

  Day 15 (+/-3d) Day 36 (+/-3d)

• Clinical effect of tDCS Beck-Inventory of Depression-II score

  Day 15 (+/-3d) Day 36 (+/-3d)

• Clinical effect of tDCS Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score

  Day 15 (+/-3d) Day 36 (+/-3d)

• maintenance effect of tDCS 17 item Hamilton Depression rating Scale score

  Day 15 (+/-3d) Day 36 (+/-3d)

• maintenance effect of tDCS Beck-Inventory of Depression-II score

  Day 15 (+/-3d) Day 36 (+/-3d)

Study Arms (2)

Active adTMS

ACTIVE COMPARATOR

Subjects in the treatment arm receive 20 sessions of real adTMS . The sessions will be spread over the four succeeding days (5 sessions daily on Tuesday, Wednesday, Thursday and Friday).

Device: a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil

Sham adTMS

SHAM COMPARATOR

Subject in the control/Placebo/Sham arm receive 20 sessions of sham adTMS. The sessions will be spread over the four succeeding days (5 sessions daily on Tuesday, Wednesday, Thursday and Friday).

Device: a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil

Interventions

a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil DEVICE

3 weeks home use

Also known as: Sooma tDCS (open label)

Active adTMS; Sham adTMS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify 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 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.

You may not qualify 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 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.

Sponsors & Collaborators

• Universitair Ziekenhuis Brussel: lead

Study Sites (1)

UZ Brussel

Jette, Brussels Capital, 1090, Belgium

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Dieter Zeeuws, MD

  Universitair Ziekenhuis Brussel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dieter Zeeuws, MD

CONTACT

+324763459; dieter.zeeuws@uzbrussel.be

Chris Baeken, MD Phd

CONTACT

+324776425; Chris.Baeken@uzbrussel.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All subjects will be assigned to one of the treatment arms by use of the top card from a stack of pre-coded cards which were prepared by an independent coder. The card has to be entered in machine in order to operate it and can be an activator of either sham or active treatment (both are integrated in and delivered by the same helmet coil.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dieter Zeeuws, MD, Head of Clinic in psychiatry

Model Details: In a sham-controlled randomized controlled trial, we will treat 44 geriatric depressed patients with accelerated dTMS (adTMS) (5 sessions/day over 4 days) and evaluate clinical efficacy and safety. One week after the last adTMS or sham treatment, all patients will have access to active treatment in a 3 week open label transcutaneous direct current stimulation (tDCS) with a home-use device. In this manner we can examine clinical effect of tDCS in the adTMS-sham group as well as the possible maintenance effect of tDCS in the adTMS active treatment group. Because newly introduced neuromodulation paradigms should go through profound neurobiological testing before applying them on a regular basis, this research will include multimodal brain imaging techniques to elucidate the working mechanisms of these applications in order to optimize response prediction and treatment

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: March 5, 2021
• Study Start: May 7, 2021
• Primary Completion: February 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: After publication of results
• Access Criteria: research

Locations

BE (1)