Home Transcranial Direct Current Stimulation (tDCS) to Enhance Functional Recovery
- Conditions
- StrokeNeurodegenerationBrain Tumor
- Registration Number
- NCT07091396
- Lead Sponsor
- Mayo Clinic
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 55
- 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).
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test 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).
For patients with post-stroke language impairment--Mayo-developed web-based language 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 Outcome Measures
Name Time Method Communicative Participation Item Bank Baseline, 12 weeks, 24 weeks For patients with aphasia, this test will be used to measure functional impairment for speech and language functions
For patients with post-stroke language impairment--Western Aphasia Battery-Revised Bedside Version 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.
Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) 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.
Change in Epworth Sleepiness Scale (ESS) 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.
Karolinska Sleepiness Scale (KSS) 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).
Trial Locations
- Locations (1)
Mayo Clinic in Rochester
🇺🇸Rochester, Minnesota, United States
Mayo Clinic in Rochester🇺🇸Rochester, Minnesota, United States