Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
Status unconfirmed · Not applicable
Conditions studied: Major Depressive Disorder
In brief
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.
Key facts
- Study ID
- NCT05205915
- Run by
- Neuroelectrics Corporation
- People needed
- 34
- Starts
- 2022-02-02
- Expected to finish
- 2022-12-01
- Last updated by the study team
- 2022-10-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- 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
Full record on ClinicalTrials.gov
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