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

Primary Purpose

Major Depressive Disorder

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS intervention applied by Starstim device
Sponsored by
Neuroelectrics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Major Depressive Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Healthcare Innovations Institute, LLC
  • Oceane7 Medical & Research Center, Inc.
  • Renew Health Clinical Research, LLC
  • Conrad Clinical Research

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm

Arm Description

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).

Outcomes

Primary Outcome Measures

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
Incidence of Serious Adverse Events (SAE)
Safety will be assessed by number and type of side effects
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

Secondary Outcome Measures

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
Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score
Range [0,27]. Higher is worse
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score
Range [14,70]. Higher is better
Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores

Full Information

First Posted
December 20, 2021
Last Updated
October 4, 2022
Sponsor
Neuroelectrics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05205915
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 2, 2022 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neuroelectrics Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. Study Description

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: Three tDCS sessions applied once every other day. Three tDCS sessions applied once every third day. Three tDCS sessions applied once every fourth day.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single arm
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
tDCS intervention applied by Starstim device
Other Intervention Name(s)
Starstim
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of incomplete and missed sessions (%)
Description
Feasibility will be evaluated using home-based data as recorded in the Neuroelectrics portal. Range [0,100]. Higher is worse
Time Frame
From baseline to 4-week follow up across study subjects
Title
Incidence of Serious Adverse Events (SAE)
Description
Safety will be assessed by number and type of side effects
Time Frame
From baseline to 4-week follow up across study subjects
Title
Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores
Description
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
Time Frame
From baseline to 4-week follow up across study subjects
Secondary Outcome Measure Information:
Title
Response rate
Description
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
Time Frame
From baseline to the 4-week follow-up
Title
Change in the Quick Inventory of Depressive Symptomatology (QIDS-SR) score
Description
Range [0,27]. Higher is worse
Time Frame
Change from baseline to 4-week follow-up in the participant-rated Quick Inventory of Depressive Symptomatology (QIDS-SR)
Title
Change in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF) score
Description
Range [14,70]. Higher is better
Time Frame
Change from baseline to 4-week follow-up in the Quality of Life Enjoyment and Satisfaction Questionnaire Short Form (Q-LES-Q-SF)
Title
Median percentage change in Montgomery-Asberg Depression Mood Rating Scale (MADRS) scores
Time Frame
From baseline to the end of week 4 of treatment, and to the end of week 8 of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Facility Information:
Facility Name
Healthcare Innovations Institute, LLC
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Oceane7 Medical & Research Center, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33144
Country
United States
Facility Name
Renew Health Clinical Research, LLC
City
Snellville
State/Province
Georgia
ZIP/Postal Code
30078
Country
United States
Facility Name
Conrad Clinical Research
City
Edmond
State/Province
Oklahoma
ZIP/Postal Code
73013
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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