Clinical trial NCT05205915: Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
Official title: Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Neuroelectrics Corporation
Sponsor class: INDUSTRY
First posted: 2022-01-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

1. Major Depressive Disorder
2. Age \>=18
3. Currently experiencing a major depressive episode of at least four weeks' duration
4. MADRS score at least 20 at trial entry.
5. Taking at least one approved antidepressant medication (except bupropion).
6. Has a healthcare provider, and a companion who can help administer study treatments; and be able to connect frequently with study staff
7. Access to wireless internet (wifi) connection

Exclusion Criteria:

1. Any psychotic disorder.
2. Concurrent benzodiazepine medication.
3. High suicide risk
4. History of significant neurological disorder.
5. Skin lesions on the scalp at the proposed electrode sites.
6. Pregnancy.
7. Any antidepressant medications will be permitted (except bupropion) provided the medication dose has been unchanged for 4 weeks prior to trial entry.
8. Any cranial metal implants (excluding ≤1 mm thick epicranial titanium skull plates and dental fillings) or
9. Medical devices (i.e. cardiac pacemaker, deep brain stimulator, medication infusion pump, cochlear implant, vagus nerve stimulator);
10. 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.
11. Substance use disorder (including alcohol) within the past year.

Primary outcomes:
measure: Percentage of incomplete and missed sessions (%)
timeFrame: From baseline to 4-week follow up across study subjects
measure: Incidence of Serious Adverse Events (SAE)
timeFrame: From baseline to 4-week follow up across study subjects
measure: Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores
timeFrame: From baseline to 4-week follow up across study subjects
Secondary outcomes:
measure: Response rate
timeFrame: From baseline to the 4-week follow-up
measure: Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score
timeFrame: Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR)
measure: Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score
timeFrame: Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
measure: Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores
timeFrame: From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment.
Other outcomes:
Locations:
city: Coral Springs
country: United States
facility: Healthcare Innovations Institute, LLC
state: Florida
city: Miami
country: United States
facility: Oceane7 Medical & Research Center, Inc.
state: Florida
city: Snellville
country: United States
facility: Renew Health Clinical Research, LLC
state: Georgia
city: Edmond
country: United States
facility: Conrad Clinical Research
state: Oklahoma
Study officials:
References: