Brain Tumor, Neurodegeneration, Stroke
Conditions
Keywords
Transcranial Direct Current Stimulation (TDCS)
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.
Interventions
DEVICESoterix® 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 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.
BEHAVIORALCognitive-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)
DEVICESoterix® 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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRene Utianski, PhD
Mayo Clinic
Outcome results
None listed