Enrolling by invitation NCT07091396
Home Transcranial Direct Current Stimulation (tDCS) to Enhance Functional Recovery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Soterix® tDCS - Home treatment, Cognitive-linguistic therapy, Soterix® tDCS - Lab treatment.
- Who it may be relevant to
- Registry conditions: Stroke, Neurodegeneration, Brain Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Enhancing Functional Recovery With Home-based Transcranial Direct Current Stimulation (tDCS) in Patients With Stroke, Neurodegeneration and Brain Tumors
Overview
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.
Interventions
- Device Soterix® tDCS - Home treatment
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 o - Behavioral Cognitive-linguistic therapy
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) - Device Soterix® tDCS - Lab treatment
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 outcome measures
- For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test [Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
- For patients with post-stroke language impairment--Mayo-developed web-based language [Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
Secondary outcome measures (5)
- For patients with post-stroke language impairment--Western Aphasia Battery-Revised Bedside Version [Time frame: Baseline, 12 weeks, 24 weeks]
- Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F) [Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
- Change in Epworth Sleepiness Scale (ESS) [Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks]
- Karolinska Sleepiness Scale (KSS) [Time frame: 10 minutes before and after each treatment session]
- Communicative Participation Item Bank [Time frame: Baseline, 12 weeks, 24 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07091396 · 24-006350