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

Mayo Clinic

Status: Invitation-only

Conditions: Neurodegeneration; Stroke; Brain Tumor

Treatments: Device: Soterix® tDCS - Lab treatment; Device: Soterix® tDCS - Home treatment; Behavioral: Cognitive-linguistic therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07091396

24-006350

Details and patient eligibility

About

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.

Enrollment: 55 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

55 participants in 4 patient groups

Home-Based Treatment: Active Stimulation, Then Sham Stimulation

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-linguistic therapy

Device: Soterix® tDCS - Home treatment

Home-Based Treatment: Sham Stimulation, Then Active Stimulation

Experimental group

Description:

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.

Treatment:

Behavioral: Cognitive-linguistic therapy

Device: Soterix® tDCS - Home treatment

Lab-Based Treatment: Active Stimulation, Then Sham Stimulation

Experimental group

Description:

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.

Treatment:

Device: Soterix® tDCS - Lab treatment

Lab-Based Treatment: Sham Stimulation, Then Active Stimulation

Experimental group

Description:

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.

Treatment:

Device: Soterix® tDCS - Lab treatment