Home Transcranial Direct Current Stimulation (tDCS) to Enhance Functional Recovery

NCT07091396 | Enrolling By Invitation FDA Device

• 1 other identifier: 24-006350
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the feasibility of home-based Transcranial Direct Current Stimulation (tDCS) combined with a home activity based therapy program in patients with stroke, brain tumors or neurodegenerative conditions and to assess the efficacy of home-based tDCS combined with a home activity-based therapy program as an intervention to treat cognitive-linguistic impairments related to stroke, brain tumors, or neurodegenerative conditions and improve quality of life.

Conditions

Stroke; Neurodegeneration; Brain Tumor

Keywords

Transcranial Direct Current Stimulation (TDCS)

Outcome Measures

Primary Outcomes (2)

• For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test

  The Stricker Learning Span (SLS) is a computer-adaptive digital word list memory test specifically designed for remote assessment and self-administration on a web-based multi-device platform (Mayo Test Drive).

  Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

• For patients with post-stroke language impairment--Mayo-developed web-based language

  The exam includes a standard protocol including sentence and word repetition, standard reading passage, vowel prolongation, speech alternating motion rates , sequential motion rates, picture description, naming, and animal fluency

  Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

Secondary Outcomes (5)

• For patients with post-stroke language impairment--Western Aphasia Battery-Revised Bedside Version

  Baseline, 12 weeks, 24 weeks

• Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)

  Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

• Change in Epworth Sleepiness Scale (ESS)

  Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

• Karolinska Sleepiness Scale (KSS)

  10 minutes before and after each treatment session

• Communicative Participation Item Bank

  Baseline, 12 weeks, 24 weeks

Study Arms (4)

Home-Based Treatment: Active Stimulation, Then Sham Stimulation

EXPERIMENTAL

Subjects will first receive active tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based sham treatment arm after a 4-8-week washout period.

Device: Soterix® tDCS - Home treatment; Behavioral: Cognitive-linguistic therapy

Home-Based Treatment: Sham Stimulation, Then Active Stimulation

EXPERIMENTAL

Subjects will first receive sham tDCS, plus home activity based cognitive-linguistic therapy then they will cross over to the home-based active treatment arm after a 4-8-week washout period.

Device: Soterix® tDCS - Home treatment; Behavioral: Cognitive-linguistic therapy

Lab-Based Treatment: Active Stimulation, Then Sham Stimulation

EXPERIMENTAL

Subjects will be seen in person to first receive active tDCS for 12 sessions over 4 weeks, and cross-over to the lab-based sham treatment arm after an 8 week washout period.

Device: Soterix® tDCS - Lab treatment

Lab-Based Treatment: Sham Stimulation, Then Active Stimulation

EXPERIMENTAL

Subjects will be seen in person to first receive sham tDCS for 12 sessions over 4 weeks, and cross-over to the lab-based active treatment arm after an 8 week washout period.

Device: Soterix® tDCS - Lab treatment

Interventions

Soterix® tDCS - Home treatment DEVICE

Participants will receive transcranial direct current stimulation (tDCS) via the Soterix device at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and ramp-down of the current. Each participant will be asked to perform tDCS on weekdays for two-weeks (10 sessions total) or every other weekday for four weeks (12 sessions). The research team will decide on a number of therapy sessions depending on the patient's baseline condition and tolerance. Patients who receive 10 sessions of therapy over two weeks will have 4 weeks of washout. Patients who receive 12 sessions over four weeks will have 8 weeks of washout.

Home-Based Treatment: Active Stimulation, Then Sham Stimulation; Home-Based Treatment: Sham Stimulation, Then Active Stimulation

Cognitive-linguistic therapy BEHAVIORAL

Participants will be instructed to perform home activity based cognitive-linguistic task-based exercises. Each participant will be asked to perform tDCS concurrently with individualized activity based cognitive-linguistic therapy on weekdays for two-weeks (10 sessions total) or every other weekday for four weeks (12 sessions)

Home-Based Treatment: Active Stimulation, Then Sham Stimulation; Home-Based Treatment: Sham Stimulation, Then Active Stimulation

Soterix® tDCS - Lab treatment DEVICE

Participants will receive transcranial direct current stimulation (tDCS) in person, via the same Soterix device the home based participants will use at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and ramp-down of the current. They will undergo 12 sessions over four weeks.

Lab-Based Treatment: Active Stimulation, Then Sham Stimulation; Lab-Based Treatment: Sham Stimulation, Then Active Stimulation

Eligibility Criteria

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

You may qualify if:

• At least 3 months after ischemic/hemorrhagic/anoxic stroke or 3 months after completion of cranial radiation or cranial surgery for treatment of primary or metastatic intracranial tumors or neurodegenerative conditions include, but are not limited to, primary progressive aphasia, corticobasal syndrome, progressive supranuclear palsy, Parkinson's disease, and Alzheimer's disease dementia.
• Expected survival \>6 months
• Functional impairment in the domains of language and/or cognition affecting quality of life determined by PI.
• Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia).
• Have a legally authorized representative who is able to sign on their behalf in unable to consent for themselves (ex., individuals with aphasia).

You may not qualify if:

• Pregnancy
• Contraindication to tDCS, including metallic implanted objects.
• Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
• Individuals with epilepsy

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Stroke; Nerve Degeneration; Brain Neoplasms

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Zafer Keser, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 29, 2025
• Study Start: January 16, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): December 1, 2031
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)