RECRUITING

Home-Based tDCS Treatment Of Major Depressive Disorder

Conditions

Major Depressive Disorder (MDD)Depression Brain stimulation Brain Sooma tDCS tES

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The REACH-tDCS study will evaluate the safety and efficacy of a noninvasive, at-home self-administered Sooma tDCS brain stimulation treatment for Major Depressive Disorder. The study uses randomized, blinded, placebo controlled design. The participants are assessed with video interviews and self-reports during the study, which lasts for 10 weeks followed by an optional continuation period.

Official Title

Safety And Efficacy of Remotely Supervised Home-Based tDCS Treatment Of Major Depressive Disorder

Quick Facts

Study Start:2025-05-15

Study Completion:2026-03-23

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06976697

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.

Ages Eligible for Study:22 Years to 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 22 - 70 years of age * Diagnosis of Unipolar MDD (DSM-V) * PHQ-9 score of ≥13 AND MADRS score of ≥ 20 at baseline * Antidepressant medication ongoing * If in psychotherapy, have maintained stable psychotherapy * Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+ * Be under the care of a psychiatrist or a primary care physician * Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years * Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence. * Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study * Be willing and able to comply with all study procedures * Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study * Be able to understand, speak, and read English sufficient for the completion of trial assessments	* Current state of mania or psychosis, or have a history of mania or psychosis. * Treatment resistant depression. * Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator. * Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation. * Have moderate or greater suicidality risk, or an attempt of suicide during lifetime or any previous hospitalization for suicidal behavior. * Have sleep apnea (unless they are on CPAP treatment and are compliant with treatment) or a diagnosis of insomnia that is unrelated to depression, as determined by the investigator. * Have any structural lesion or any neurocranial defect or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator. * Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device anywhere in the body (e.g. pacemaker, insulin pump). * Have a history of epilepsy or seizures. * Have shrapnel or any ferromagnetic material in the head. * Have any disorder that would impair the ability to complete the study questionnaires. * Have been diagnosed with autism spectrum disorder. * Have an alcohol use disorder or substance use disorder (past 12 months). * Have a cognitive impairment (including dementia). * medications that affect cortical excitability, as determined by the investigator. * Have ever taken esketamine / ketamine for treatment of depression. * Are currently admitted or have ever been admitted to the hospital for depression. * Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1 or 2 disorder. * Be diagnosed with an active primary anxiety disorder, or PTSD, agoraphobia, anorexia or bulimia, panic or personality disorder with active symptoms, based on the investigator's judgment. * Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues. * Be currently experiencing or have a history of intractable migraines. * Be a chronic tobacco smoker. * Be currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study, or lack a medically acceptable method of contraception in females with child-bearing potential. * Be currently incarcerated. * Be participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study. * Have a hairstyle or hair type, such as very thick hair or voluminous hairstyle, that would prevent wearing of the treatment cap tightly enough on the head that the electrodes are held close to the scalp.

Inclusion Criteria

Exclusion Criteria

* 22 - 70 years of age
* Diagnosis of Unipolar MDD (DSM-V)
* PHQ-9 score of ≥13 AND MADRS score of ≥ 20 at baseline
* Antidepressant medication ongoing
* If in psychotherapy, have maintained stable psychotherapy
* Have access to a smartphone or other device running Android 7.0+ or iPhone Operating System (iOS) 13+
* Be under the care of a psychiatrist or a primary care physician
* Allow communication between the investigators/study staff and any healthcare provider who currently provides and/or has provided service to the patient/subject within at least two years
* Provide the name and contact of at least two adult persons who reside within a 60-minute drive of the patient's residence.
* Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
* Be willing and able to comply with all study procedures
* Agree to meet all of the inclusion criteria throughout their participation in the study. Otherwise, the subject will be discontinued from the study
* Be able to understand, speak, and read English sufficient for the completion of trial assessments

* Current state of mania or psychosis, or have a history of mania or psychosis.
* Treatment resistant depression.
* Are diagnosed with vitamin or hormonal deficiencies that may mimic mood disorders, as determined by the investigator.
* Be currently receiving any other interventional therapy for MDD other than a stable regimen of antidepressants or psychotherapy as defined in the inclusion criteria or have a history of electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), deep brain stimulation (DBS), or other brain stimulation.
* Have moderate or greater suicidality risk, or an attempt of suicide during lifetime or any previous hospitalization for suicidal behavior.
* Have sleep apnea (unless they are on CPAP treatment and are compliant with treatment) or a diagnosis of insomnia that is unrelated to depression, as determined by the investigator.
* Have any structural lesion or any neurocranial defect or any other clinically significant abnormality that might affect safety, study participation, or confound interpretation of study results, as determined by the investigator.
* Have any implant in the brain (e.g., DBS) or neurocranium, or any other active implantable medical device anywhere in the body (e.g. pacemaker, insulin pump).
* Have a history of epilepsy or seizures.
* Have shrapnel or any ferromagnetic material in the head.
* Have any disorder that would impair the ability to complete the study questionnaires.
* Have been diagnosed with autism spectrum disorder.
* Have an alcohol use disorder or substance use disorder (past 12 months).
* Have a cognitive impairment (including dementia).
* medications that affect cortical excitability, as determined by the investigator.
* Have ever taken esketamine / ketamine for treatment of depression.
* Are currently admitted or have ever been admitted to the hospital for depression.
* Have ever been diagnosed with obsessive-compulsive disorder (OCD) or bipolar type 1 or 2 disorder.
* Be diagnosed with an active primary anxiety disorder, or PTSD, agoraphobia, anorexia or bulimia, panic or personality disorder with active symptoms, based on the investigator's judgment.
* Have any history of myocardial infarction, coronary artery bypass graft (CABG), coronary heart failure (CHF), or history of other cardiac issues.
* Be currently experiencing or have a history of intractable migraines.
* Be a chronic tobacco smoker.
* Be currently pregnant or breastfeeding or planning to become pregnant or breastfeed any time during the study, or lack a medically acceptable method of contraception in females with child-bearing potential.
* Be currently incarcerated.
* Be participating concurrently in another clinical investigation or have participated in a clinical investigation within the last 90 days or intend to participate in another clinical investigation during the study.
* Have a hairstyle or hair type, such as very thick hair or voluminous hairstyle, that would prevent wearing of the treatment cap tightly enough on the head that the electrodes are held close to the scalp.

Contacts and Locations

Principal Investigator

Christopher Reist, M.D.

PRINCIPAL_INVESTIGATOR

Study Locations (Sites)

Lindus Health virtual site

New York, New York, 10017

United States

Collaborators and Investigators

Sponsor: Sooma Medical Inc

Christopher Reist, M.D., PRINCIPAL_INVESTIGATOR

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 Registration Dates

Study Start Date2025-05-15

Study Completion Date2026-03-23

Study Record Updates

Study Start Date2025-05-15

Study Completion Date2026-03-23

Terms related to this study

Keywords Provided by Researchers

Depression
Brain stimulation
Brain
Sooma
tDCS
tES

Additional Relevant MeSH Terms

Major Depressive Disorder (MDD)