Home-based Transcranial Direct Current Stimulation (tDCS) for Major Depressive Disorders (MDD)

NCT ID: NCT05205915

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-02
• Study Completion Date: 2022-12-31

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.

Conditions

Major Depressive Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Single arm

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).

Group Type: EXPERIMENTAL

tDCS intervention applied by Starstim device

Intervention Type: 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.

Interventions

tDCS intervention applied by Starstim 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.

Intervention Type: DEVICE

Other Intervention Names

Starstim

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neuroelectrics Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39211540 (View on PubMed)

Other Identifiers

NE02

Identifier Type: -

Identifier Source: org_study_id