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This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.
This is an open label pilot feasibility telemedicine study. This pilot will involve a total of 37 at-home stimulation sessions (30-minutes each) of multichannel excitatory tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) administered over 8 weeks, with a follow-up period of 4 weeks following the final stimulation session.
The main objective of the study is to assess the feasibility and safety of home-based tDCS for patients with MDD.
The treatment course will consist of an acute phase of 28 tDCS sessions, conducted daily (7 days per week) over 4 weeks.
Thereafter, participants will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm | Experimental | All patients will receive active treatment which consists of stimulation (tDCS) applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tDCS intervention applied by Starstim device | Device | Stimulation will be applied using the Starstim device, with current delivered via four Starstim Pi electrodes (circular electrodes with a contact of area of 3.14 cm2) embedded in the headpiece. All study subjects will use the same fixed montage (electrode locations and currents). The montage has been designed to optimize anodal stimulation in the desired target area while avoiding stimulation off target. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of incomplete and missed sessions (%) | Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range [0,100]. Higher is worse | From baseline to 4-week follow up across study subjects |
| Incidence of Serious Adverse Events (SAE) | Safety will be assessed by number and type of side effects | From baseline to 4-week follow up across study subjects |
| Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores | The primary efficacy measure for this study will be the median percent change from baseline to the end of the 4-week post-treatment follow-up period in the observer-rated Montgomery-Asberg Depression Mood Rating Scale (MADRS) (Montgomery and Asberg, 1979). Range [0,100]. Higher is worse | From baseline to 4-week follow up across study subjects |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate | Response rate is the secondary efficacy endpoint and will be calculated for the study subjects, where clinical response is defined as ≥ 50% improvement in Montgomery-Asberg Depression Mood Rating Scale (MADRS) score. Higher is better | From baseline to the 4-week follow-up |
| Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Healthcare Innovations Institute, LLC | Coral Springs | Florida | 33067 | United States | ||
| Oceane7 Medical & Research Center, Inc. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39211540 | Derived | Ruffini G, Salvador R, Castaldo F, Baleeiro T, Camprodon JA, Chopra M, Cappon D, Pascual-Leone A. Multichannel tDCS with advanced targeting for major depressive disorder: a tele-supervised at-home pilot study. Front Psychiatry. 2024 Aug 15;15:1427365. doi: 10.3389/fpsyt.2024.1427365. eCollection 2024. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 29, 2023 | |
| Reset | Feb 14, 2024 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 29, 2023 | Feb 14, 2024 |
| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Range [0,27]. Higher is worse |
| Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR) |
| Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score | Range [14,70]. Higher is better | Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) |
| Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores | From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment. |
| Miami |
| Florida |
| 33144 |
| United States |
| Renew Health Clinical Research, LLC | Snellville | Georgia | 30078 | United States |
| Conrad Clinical Research | Edmond | Oklahoma | 73013 | United States |