Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
- Conditions
- Major Depressive Disorder
- Registration Number
- NCT05205915
- Lead Sponsor
- Neuroelectrics Corporation
- Brief Summary
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.
- Detailed Description
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:
1. Three tDCS sessions applied once every other day.
2. Three tDCS sessions applied once every third day.
3. Three tDCS sessions applied once every fourth day.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 34
- Major Depressive Disorder
- Age >=18
- Currently experiencing a major depressive episode of at least four weeks' duration
- MADRS score at least 20 at trial entry.
- Taking at least one approved antidepressant medication (except bupropion).
- Has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff
- Access to wireless internet (wifi) connection
- Any psychotic disorder.
- Concurrent benzodiazepine medication.
- High suicide risk
- History of significant neurological disorder.
- Skin lesions on the scalp at the proposed electrode sites.
- Pregnancy.
- Any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry.
- Any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or
- Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator);
- Previous surgeries opening the skull leaving skull defects capable of allowing the insertion of a cylinder with a radius greater or equal to 5 mm.
- Substance use disorder (including alcohol) within the past year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Percentage of incomplete and missed sessions (%) From baseline to 4-week follow up across study subjects Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range \[0,100\]. Higher is worse
Incidence of Serious Adverse Events (SAE) From baseline to 4-week follow up across study subjects Safety will be assessed by number and type of side effects
Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores From baseline to 4-week follow up across study subjects 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
- Secondary Outcome Measures
Name Time Method Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) Range \[14,70\]. Higher is better
Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR) Range \[0,27\]. Higher is worse
Response rate From baseline to the 4-week follow-up 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
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.
Trial Locations
- Locations (4)
Healthcare Innovations Institute, LLC
🇺🇸Coral Springs, Florida, United States
Oceane7 Medical & Research Center, Inc.
🇺🇸Miami, Florida, United States
Renew Health Clinical Research, LLC
🇺🇸Snellville, Georgia, United States
Conrad Clinical Research
🇺🇸Edmond, Oklahoma, United States
Healthcare Innovations Institute, LLC🇺🇸Coral Springs, Florida, United States