An interventional study of a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil in Old Age and Depressive Disorder, Treatment-Resistant, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2022-11-03.
Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Treatment
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
With a growing number of elderly persons, geriatric depression - associated with important morbidity and mortality- is becoming a significant health problem. Given the risk of polypharmacy and increased side effects, alternative non pharmaceutical treatments such as repetitive transcranial magnetic stimulation (rTMS) and transcutaneous direct current stimulation (tDCS) may offer a solution. Given our recent positive results with accelerated rTMS in the elderly depressed, we want to continue to develop non-invasive treatment stimulations. The FDA approved deep brain TMS (dTMS) technique may be a promising option, targeting the brain underneath the neocortex with potentially better response and remission rates. Therefore, in a sham-controlled randomized controled trial, we will treat 44 geriatric depressed patients with accelerated dTMS (5 sessions/day over 4 days only), 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 clinnical effect of tDCS in the adTMS-sham group as well as the possible maintenance effect of tDCS in the adTMS active treatment group. Because new introduced neuromodulation paradigms should be rigorously neurobiologically examined 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. Gut microbes can influence human metabolism, nutrition, physiology and immune status. The "microbiota-gut-brain axis" entails a continues exchange of information between the gut and central nervous system. Several clinical and preclinical studies have emphasized the bidirectional role of microbiome disruption in depression and depression-like behavior. In the current project, we also will examine the effects of neurostimulation treatments on the gut microbiome.
472 studies on the registry are indexed under Depressive Disorder, Treatment-Resistant; 151 are open to participants now.
This study's planned enrollment of 44 is below the median of 51 across 397 interventional studies indexed under Depressive Disorder, Treatment-Resistant.
Browse Depressive Disorder, Treatment-Resistant studies →Universitair Ziekenhuis Brussel is the lead sponsor of 374 studies on the registry; 106 are open to participants now.
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In- and outpatients (age 65 year or older).
Exclusion Criteria:
Psychosis (except depression with psychotic features).
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
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
3 weeks home use
Also known as: Sooma tDCS (open label)
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)
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)
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)
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)
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)
maintenance effect of tDCS Beck-Inventory of Depression-II 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 BDI-II score decrease of 50% from baseline in the Beck-Inventory of Depression-II 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)
functional magnetic resonance imaging changes pre/post treatment in gender task as an incidental measure of emotional processing and probe of limbic function, and it's predictive value for response
To investigate if the fMRI gender task provides an incidental measure of emotional processing and could be a better probe of limbic function, and it's predictive value for response to adTMS and/or tDCS.To look for change post-pre intervention in the fMRI gender task response.
Time frame: Day 1 (+/-3d), Day 8 (+/-3d)
effect on cognition MMSE
To investigate the effect of adTMS and tDCS on cognition as measured by increase in Mini Mental State examination scores.Scores range from 0 to 30, a score increase indicates improvement.
Time frame: screening, Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
Incidence of Treatment-Emergent Adverse Events assessed with the Adverse Events questionnaire
To investigate the safety profile of adTMS and tDCS for elderly with MDD
Time frame: Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on suicide risk as measured by change in C-SSRS
To investigate the effect of adTMS and tDCS on suicide risk of elderly patients with MDD.
Time frame: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on suicide risk as measured by change in BSI
To investigate the effect of adTMS and tDCS on suicide risk of elderly patients with MDD.
Time frame: screening, Day 1 (+/-3d), Day 8 (+/-3d) ,Day 15 (+/-3d) Day 36 (+/-3d)
effect on the gut microbiome
To investigate the effect of neurostimulation on the gut microbiome in elderly with MDD.
Time frame: Day 1 (+/-3d), Day 8 (+/-3d) Day 36 (+/-3d)
possible neuroimaging biological markers for response
To investigate possible neurobiological markers for response to adTMS and/or tDCS by neuro imaging changes after adTMS and/or tDCS compared to baseline. Pre/Post changes in resting state fMRI en ASL (bloodflow) images.
Time frame: Day 1 (+/-3d), Day 8 (+/-3d) Day 36 (+/-3d)
Plan to share: Yes — All data will be disclosed after publication
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After publication of results
Access criteria: research
No publications or documents are linked to this record.
Started May 2021 (actual). Primary completion is estimated for Feb 2025, 45 months after the start.
Of 139 non-industry interventional studies with no phase under Depressive Disorder, Treatment-Resistant, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 76. This study's planned 45 months is above that.
Counting every sponsor, half of 142 studies reached it within 42 months; a quarter within 22 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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