Transcranial Direct Current Stimulation (tDCS) as an Adjunctive Treatment for Treatment Resistant Depression (TRD)

NCT06236711 | Active Not Recruiting FDA Device

• 1 other identifier: 23-003274
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The researchers are trying to test the feasibility and acceptability of using transcranial Direct Current Stimulation (tDCS) in hospitalized adult patients with Treatment Resistant Depression (TRD), assess for any preliminary effect on depressive and cognitive symptoms, and explore the utility of biomarkers to assess response to tDCS.

Conditions

Treatment Resistant Depression

Outcome Measures

Primary Outcomes (3)

• Feasibility outcome

  Defined as 70% of eligible patients choosing to enroll in the study. Other feasibility parameters will include willingness of clinicians to refer and help recruit patients, number of eligible participants, willingness of participants to enroll, retention of patients, and completeness of data collection.

  through study completion, an average of 2 weeks

• Acceptability outcome

  Defined as 80% of study participants completing 80% of the 10-session tDCS treatment protocol. Investigators will also ask participants about their satisfaction, perceptions, and experiences with the tDCS treatments. Other acceptability parameters will include rates of adherence to tDCS protocol, dropout rates and reasons for non-completion.

  through study completion, an average of 2 weeks

• Tolerability outcome

  Defined as an overall tolerability rating of "very tolerable." This will be a self-report based on a global question "Considering all aspects of your experience, how would you rate the overall tolerability of the tDCS intervention?" The response options are: very tolerable, somewhat tolerable, neutral, somewhat intolerable, and very intolerable. Other tolerability parameters will include the tDCS adverse effects questionnaire.

  through study completion, an average of 2 weeks

Secondary Outcomes (6)

• Change in Montgomery-Asberg Depression Rating Scale (MADRS)

  baseline, 2 weeks

• Change in Snaith-Hamilton Pleasure Scale (SHAPS)

  baseline, 2 weeks

• Change in Stroop Test

  baseline, 2 weeks

• Change in Revised Hopkins Verbal Learning Test (HVLT-R)

  baseline, 2 weeks

• Change in Digital Symbol Coding Test (DSCT)

  baseline, 2 weeks

Study Arms (1)

tDCS interventional arm

EXPERIMENTAL

Participants will receive a 30-minute tDCS treatments at 2 mA twice daily over the course of 5 days.

Device: tDCS

Interventions

tDCS DEVICE

tDCS is a form of noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes. The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A (Soterix Medical, Inc., New York, NY, USA) device will be used in the study. The tDCS device is comprised of a small battery-operated control box that delivers the current through electrodes placed on the scalp, held in place by elastic bands or head straps and worn over the forehead like a headband.

tDCS interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• Clinical diagnosis of treatment-resistant depression (defined as depression that does not remit following two or more treatment attempts of an adequate dose and duration of a minimum duration of 4 weeks)
• Hospitalized in psychiatric units
• Voluntary admission status
• Moderate or severe depression, defined by PHQ-9 ≥ 15
• Ability to provide informed consent
• Ability to adhere to protocol

You may not qualify if:

• Bipolar disorder
• Active primary psychotic or substance use disorders (except nicotine dependence) within the past year
• Any active neurological condition (including seizure disorder, traumatic brain injury, stroke)
• Contraindications to tDCS (including pacemaker, metallic implants in the head or neck \[except orthodontic hardware\], skin disease causing irritation)
• Current pregnancy or positive urine pregnancy test (clinical)
• Any neuromodulation therapy (including ECT, rTMS, DBS, VNS, TES) within the last 3 months

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Li JW, Ren C, Pazdernik VK, Kung S, Basso MR, Croarkin PE, Aaron B, Anderson AM, Caves CA, Hemm MN, Holland AL, Hoth CR, Jazdzewski EA, Kabristante E, Kandimalla M, Mickle CB, Min HK, Ozger C, Parsons JM, Sheldon RL, Skime MK, St Louis EK, Varatharajah Y, Wagh N, Welker KM, Williams SM, Worrell GA, Lapid MI. Transcranial direct current simulation as an adjunctive treatment for treatment-resistant depression in hospitalized patients: A feasibility study protocol. PLoS One. 2025 Jun 10;20(6):e0324808. doi: 10.1371/journal.pone.0324808. eCollection 2025.

  PMID: 40493630 DERIVED

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Depressive Disorder, Treatment-Resistant

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Maria I Lapid, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Open Label

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 1, 2024
• Study Start: March 20, 2025
• Primary Completion: October 15, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 6, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)