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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: tDCS intervention applied by Starstim device

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Springs, Florida, United States, 33067
      • Healthcare Innovations Institute, LLC
    • Miami, Florida, United States, 33144
      • Oceane7 Medical & Research Center, Inc.
  • Georgia
    • Snellville, Georgia, United States, 30078
      • Renew Health Clinical Research, LLC
  • Oklahoma
    • Edmond, Oklahoma, United States, 73013
      • Conrad Clinical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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).

Device: 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.; Other Names: Starstim

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Response rate	Response rate is the secondary efficacy endpoint and will be calculated for the study subjects, where clinical response is defined as ≥ 50% improvement in Montgomery-Asberg Depression Mood Rating Scale (MADRS) score. Higher is better	From baseline to the 4-week follow-up
Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score	Range [0,27]. Higher is worse	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	Range [14,70]. Higher is better	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.

Collaborators and Investigators

• Sponsor: Neuroelectrics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: January 12, 2022
• First Posted (Actual): January 25, 2022

Study Record Updates

• Last Update Posted (Actual): October 5, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: NE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes