Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression (HomeDC)

October 26, 2022 updated by: Daniel Keeser, Ludwig-Maximilians - University of Munich

Transcranial Direct Current Stimulation in a Home Treatment Setting for Major Depression: A Double-blind, Placebo-controlled Pilot Trial

Non-invasive transcranial brain stimulation (NTBS) techniques are well established in experimental neuroscience and have been increasingly used in the treatment of mental illnesses, especially depressive disorders, in the last years. Transcranial direct current stimulation (tDCS) of prefrontal cortex regions has been reported to exert antidepressant effects. Treatment with tDCS for MDD requires sessions several times a week, which is very time-consuming and stressful for patients, as they have to come to the clinic almost every day. At the same time, the availability of non-drug therapies for MDD is limited, especially in more rural areas. The home-treatment approach with tDCS for MDD could address this problem and is of increasing interest in times of the Covid-19 pandemic, when frequent clinic visits should be avoided.

There are some studies on the home-treatment approach with tDCS for different, mainly neurological disorders such as parkinson's disease, multiple sclerosis and chronic pain. For the treatment of MDD with tDCS in the home treatment setting, only one pilot study has been published so far, which shows good feasibility and good antidepressant effects. However, this study does not include a placebo condition.

The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with MDD do a 6-weeks self-administered treatment with prefrontal tDCS (anode: F3, cathode: F4, 5 sessions/week, 30min/day, 2mA intensity) or sham tDCS (parameters correspondent active tDCS, ramp in and ramp out periods only without intermittent stimulation) as adjunctive treatment to a serotonergic medication or alone. For the continuous monitoring of the technical parameters and thus for quality control and for blinding, the same technical achievements as in the DepressionDC trial are used. As a new feature, a cap is used for easier handling in the home-treatment setting, in which electrodes are already integrated at the F3 and F4 points.

This study aims to investigate the feasibility and effectiveness of 6 weeks of daily home treatment with tDCS for MDD. According to the DepressionDC trial, the primary outcome parameters are the decrease in the MADRS after 6 weeks and at the end of the follow-up phase, as well as the feasibility based on the dropout rates and the outcome in the comfort rating questionnaire. Additional baseline examinations with cMRI and e-field modelling will investigate the possible influence of the individual e-field on the outcome.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Design:

The study will be conducted in a double-blind, placebo-controlled, parallel-group design with 16 patients per group. Patients with primary diagnosis of MDD according to DSM-5 perform a 6-weeks self-administered treatment with prefrontal tDCS (anode over F3, cathode over F4, 5 sessions/week, 30min/day, 2mA intensity) or sham-tDCS (parameters correspondent active tDCS, ramp-in and ramp-out periods only without intermittent stimulation) as adjunctive treatment to a stable antidepressant medication or alone. The study will be conducted at the Department of Psychiatry and Psychotherapy of the LMU Munich. Suitable patients will be randomized into two groups after they passed screening. Stratification according to the severity of the depressive symptoms (MARDS<21 vs. MARDS≥21) to distribute patients according to factors influencing the clinical outcome will be also done as well as stratification according to gender. The groups will receive active tDCS or sham-tDCS for a total of 6 weeks (5x/week, 30 min. stimulation). At baseline, an optional baseline cMRI examination with e-field modelling and fMRI will be performed. During the treatment phases, a study visit will take place every 2 weeks. In addition, a study visit will take place after the first week to address any difficulties with self-application at home. After 6 weeks, the primary endpoint will be reached and a final rating will be made after the treatment phase. In the subsequent follow-up phase, a study visit (V5 and V6) will take place 4 weeks and 8 weeks after the last stimulation session. According to the rules of the DepressionDC trial (Padberg et al., 2017) a total of 4 sessions may be missed without a drop out. Missed sessions can be compensated with additional sessions in week 7. This yields a total of 6 study visits with a total protocol duration of 14 weeks. The treatment phase is 6 weeks long with a maximum of 30 tDCS sessions per patient in home treatment.

Patients which continue to have relevant depressive symptoms after the 6 weeks of active or sham tDCS and after completion of the follow up phase will be offered 6 weeks of active treatment after V5. Patients receiving the active phase after V5 will receive an additional 3 study visits with the same scales reported like V1/V2/V3 during this second study phase: V6 after the first 3 weeks of active treatment, V7 after 6 weeks and V8 as a follow up 4 weeks after completion of the second treatment phase. Effects of this second study phase will be analysed in an exploratory way on an intraindividual level.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Primary DSM-5 diagnosis of Major Depression as assessed by the M.I.N.I with a single or recurrent episode with the additional requirements of a current episode with a duration of ≥4 weeks.
  • Current depressive episode is less than 5 years duration (the definition of an episode is demarcated by a period of ≥2 months in which the patient did not meet full criteria for the DSM-5 definition of major depressive episode).
  • Total HDRS-21 ≥13 at the screening visit.
  • Patient is taking one of the following antidepressants of adequate dose and ≥2 weeks in the current Episode: SSRIs: Escitalopram, Citalopram, Sertralin, Paroxetin, Fluoxetin, Fluvoxamin; SSNRIs: Duloxetin, Venlafaxin, Milnacipran. and optional concomitant treatment with Quetiapin, Lithium und Mirtazapin.
  • Capable and willing to provide informed consent.
  • Negative pregnancy test and willingness to use contraceptive measures during study treatment for women with childbearing potential (i.e <. 2 years post-menopausal)

Exclusion Criteria:

  • Investigators, site personnel directly affiliated with this study, and their immediate families
  • Acute risk for suicide (MADRS, item 10 score of ≥4 or suicidal attempt in the present episode
  • Treatment with electroconvulsive therapy in the present episode.
  • Treatment with deep brain stimulation or vagus nerve stimulation and/or any other intracranial implants (clips, cochlear implants).
  • Any other relevant psychiatric axis-I- and/or axis-II-disorder.
  • Any relevant instable medical condition.

  • Individuals diagnosed with a significant neurological disorder or insult including, but not limited to:

    • Increased intracranial pressure
    • Space occupying brain lesion
    • History of cerebrovascular accident
    • Transient ischemic attack within two years
    • Cerebral aneurysm, dementia
    • Parkinson's disease
    • Huntington's chorea
    • Multiple sclerosis
    • Epilepsy
  • History of seizures
  • Pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Active prefrontal tDCS 2mA 6 weeks 5x/week
Device: prefrontal tDCS
2 mA prefrontal tDCS (anode over F3, cathode over F4 10/20 EEG System) for 6 weeks, 5x/week in a home treatment Setting (self application) for 30 mins.
Sham Comparator: Sham prefrontal tDCS 6 weeks 5x/week
Device: prefrontal tDCS
2 mA prefrontal tDCS (anode over F3, cathode over F4 10/20 EEG System) for 6 weeks, 5x/week in a home treatment Setting (self application) for 30 mins.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: 6 weeks
Drop out rates, number of completed stimulation sessions in the treatment phase
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 6 weeks
side effects and complications encountered, rates of discontinuation of stimulations due to high impedances, number of SAEs and AEs
6 weeks
Change in BDI, GAF and CGI
Time Frame: 10 weeks
The change in absolute score in the BDI, CGI and GAF after 6 weeks of tDCS treatment and after 4 weeks of follow up compared to the baseline scores
10 weeks
Change from baseline in the Montgomery Åsberg Depression Rating Scale (MADRS) scores at week 6 post-randomization compared to baseline
Time Frame: 6 weeks
The change in absolute score in the MADRS after 6 weeks of tDCS treatment compared to the baseline MADRS score
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ludwig-Maximilians - University of Munich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 20, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 28, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HomeDC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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