Status:
UNKNOWN
Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
Lead Sponsor:
Neuroelectrics Corporation
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
NA
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 dors...
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 dors...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 2 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT05205915
Start Date
February 2 2022
End Date
December 1 2022
Last Update
October 5 2022
Active Locations (4)
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1
Healthcare Innovations Institute, LLC
Coral Springs, Florida, United States, 33067
2
Oceane7 Medical & Research Center, Inc.
Miami, Florida, United States, 33144
3
Renew Health Clinical Research, LLC
Snellville, Georgia, United States, 30078
4
Conrad Clinical Research
Edmond, Oklahoma, United States, 73013