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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05205915
• Other study ID #: NE02
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 2, 2022
• Est. completion date: December 2022

Study information

• Verified date: October 2022
• Source: Neuroelectrics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	Healthcare Innovations Institute, LLC	Coral Springs	Florida
United States	Conrad Clinical Research	Edmond	Oklahoma
United States	Oceane7 Medical & Research Center, Inc.	Miami	Florida
United States	Renew Health Clinical Research, LLC	Snellville	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Neuroelectrics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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)
Secondary	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)
Secondary	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.