An interventional study of Soterix® tDCS - Home treatment and Cognitive-linguistic therapy in Stroke, Neurodegeneration and Brain Tumor, sponsored by Mayo Clinic. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
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.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 55 is close to the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
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Exclusion Criteria:
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
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
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
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
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.
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)
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.
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).
Time frame: 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
Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks
For patients with post-stroke language impairment--Western Aphasia Battery-Revised Bedside Version
Western aphasia battery assesses linguistic skills most frequently affected by aphasia such as content, fluency, auditory Comprehension, repetition and naming, reading, writing.
Time frame: Baseline, 12 weeks, 24 weeks
Change in Visual Analogue Scale to Evaluate Fatigue Severity (VAS-F)
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.
Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks
Change in Epworth Sleepiness Scale (ESS)
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.
Time frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks
Karolinska Sleepiness Scale (KSS)
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).
Time frame: 10 minutes before and after each treatment session
Communicative Participation Item Bank
For patients with aphasia, this test will be used to measure functional impairment for speech and language functions
Time frame: Baseline, 12 weeks, 24 weeks
Plan to share: No
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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