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

NCT05205915 | Unknown FDA Device

• 1 other identifier: NE02
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Major Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• Percentage of incomplete and missed sessions (%)

  Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range \[0,100\]. Higher is worse

  From baseline to 4-week follow up across study subjects

• Incidence of Serious Adverse Events (SAE)

  Safety will be assessed by number and type of side effects

  From baseline to 4-week follow up across study subjects

• Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores

  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

  From baseline to 4-week follow up across study subjects

Secondary Outcomes (4)

• Response rate

  From baseline to the 4-week follow-up

• 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)

• 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)

• 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.

Study Arms (1)

Single arm

EXPERIMENTAL

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).

Device: tDCS intervention applied by Starstim device

Interventions

tDCS intervention applied by Starstim device 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.

Also known as: Starstim

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Neuroelectrics Corporation: lead

Study Sites (4)

Healthcare Innovations Institute, LLC

Coral Springs, Florida, 33067, United States

Location

Oceane7 Medical & Research Center, Inc.

Miami, Florida, 33144, United States

Location

Renew Health Clinical Research, LLC

Snellville, Georgia, 30078, United States

Location

Conrad Clinical Research

Edmond, Oklahoma, 73013, United States

Location

Related Publications (1)

• 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.

  PMID: 39211540 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 25, 2022
• Study Start: February 2, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

US (4)