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Enrolling by Invitation

NCT Number: NCT07091396

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

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.

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Key information

Conditions

Stroke Brain Diseases Brain Neoplasms Brain Tumor Cardiovascular Diseases Central Nervous System Diseases Central Nervous System Neoplasms Cerebrovascular Disorders Neoplasms Neoplasms by Site Nerve Degeneration Nervous System Diseases Nervous System Neoplasms Neurodegeneration Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

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)

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.

Primary outcomes

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

    Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

    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).

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

    Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

    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

Secondary outcomes

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

    Time frame: Baseline, 12 weeks, 24 weeks

    Western aphasia battery assesses linguistic skills most frequently affected by aphasia such as content, fluency, auditory Comprehension, repetition and naming, reading, writing.

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

    Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

    The Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) is an 18 item self-report scale measuring the subject's experience of fatigue. Each item asks respondents to place an "X," representing how they currently feel, along a visual analogue line that extends between two extremes. Total scores range from 0 - 198, lower scores indicating lower levels of fatigue and higher scores indicating greater levels of fatigue.

  3. Change in Epworth Sleepiness Scale (ESS)

    Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks

    The Epworth sleepiness scale (ESS) is an 8-item questionnaire that measures daytime sleepiness in participants. Possible scores range from 0-24, with higher scores indicating a higher average sleep propensity in daily life, and a worse outcome.

  4. Karolinska Sleepiness Scale (KSS)

    Time frame: 10 minutes before and after each treatment session

    The Karolinska Sleepiness Scale (KSS) is a 9-point scale quantifying an individual's perceived level of drowsiness, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).

  5. Communicative Participation Item Bank

    Time frame: Baseline, 12 weeks, 24 weeks

    For patients with aphasia, this test will be used to measure functional impairment for speech and language functions

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Enhancing Functional Recovery With Home-based Transcranial Direct Current Stimulation (tDCS) in Patients With Stroke, Neurodegeneration and Brain Tumors

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jul 29, 2025
Registry last updated
Jan 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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