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

NCT ID: NCT06236711

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-20
• Study Completion Date: 2026-12-31

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.

Detailed Description

In this feasibility study the researchers propose to conduct a 5-day tDCS treatment protocol in hospitalized adult patients with TRD, with each treatment session lasting for 30 minutes, delivered twice daily, for a total of 10 stimulations over 5 days. Before and after the 5-day tDCS treatment protocol, assessments will include Montgomery-Asberg Depression Rating Scale (MADRS) to measure depressive symptoms, Snaith-Hamilton Pleasure Scale (SHAPS) to measure anhedonia, Stroop Test to measure memory and executive function, Revised Hopkins Verbal Learning Test (HVLT-R) to test verbal learning and memory, and Digital Symbol Coding Test (DSCT) to measure working memory. Electroencephalography (EEG) for objective electrophysiologic data will also be collected before and after tDCS. A wireless EEG unit (CGX, Cognionic, Inc.) will be used to collect EEG and peak alpha frequency (PAF) as potential target engagement marker for tDCS. The PAF measures the highest magnitude within the alpha range of brain oscillations, thought to reflect cognitive performance. Other potential predictors of treatment response measures collected at baseline include Adverse Childhood Experiences (ACE), premorbid intelligence quotient (pIQ), Wide Range Achievement Reading Test (WRART), and Socioeconomic Status (SES).

Conditions

Treatment Resistant Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

tDCS interventional arm

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

Group Type: EXPERIMENTAL

tDCS

Intervention Type: 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.

Interventions

tDCS

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 18 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Maria I. Lapid, M.D.

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria I Lapid, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40493630 (View on PubMed)

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

23-003274

Identifier Type: -

Identifier Source: org_study_id