Neuromodulation in the Elderly Depressed: a Brain Imaging Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversitair Ziekenhuis Brussel
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
• 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.
Disqualifiers
• 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).
Trial design
Design model
Parallel
Treatments tested in this trial
a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil
Device3 weeks home use
Treatment groups
44 Participants
are divided into 2 treatment groupsGroup A: Active adTMSActive comparator 1 intervention
Group B: Sham adTMSSham comparator 1 intervention
Trial outcomes
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.
Time frame
screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)Secondary outcomes
1
Clinical effect of tDCS 17 item Hamilton Depression rating Scale score
To investigate the effect of tdCS delivered by a Sooma tDCS 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.
Time frame
Day 15 (+/-3d) Day 36 (+/-3d)2
Clinical effect of tDCS Beck-Inventory of Depression-II score
To investigate the effect of tdCS delivered by a Sooma tDCS 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 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.
Time frame
Day 15 (+/-3d) Day 36 (+/-3d)3
Clinical effect of tDCS Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score
To investigate the effect of tdCS delivered by a Sooma tDCS 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 Geriatric Depression Scale 15 item version (GDS-15) self-rating scale score. Score of ≤6 is the criterion for remission and decrease of 50% from baseline is the criterion for treatment response.
Time frame
Day 15 (+/-3d) Day 36 (+/-3d)4
maintenance effect of tDCS 17 item Hamilton Depression rating Scale score
To investigate the maintenance effect of tdCS delivered by a Sooma tDCS to the left Dorsolateral Prefrontal Cortex (DLPFC), as an add-on treatment, on depressive symptoms in a sample of elderly patients with MDD who responded to active adTMS measured by reduction from baseline of ≥ 50% in the total score in the 17 item Hamilton Depression rating Scale score. Maintenance effect occurs if the responders scores at day 15 remain or are lower on day 36.
Time frame
Day 15 (+/-3d) Day 36 (+/-3d)Sponsors and contacts
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Source ClinicalTrials.gov