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

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mayo Clinic
Study ID
NCT07091396
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Soterix® tDCS - Home treatment — DEVICE
    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.
  • Cognitive-linguistic therapy — BEHAVIORAL
    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)
  • Soterix® tDCS - Lab treatment — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 16, 2026
Status verified
Jan 2026
Primary completion
Dec 31, 2030
Completion
Dec 31, 2031

Study Design

Enrollment
55 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: Home-Based Treatment: Active Stimulation, Then Sham Stimulation
    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.
  • Experimental: Home-Based Treatment: Sham Stimulation, Then Active Stimulation
    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.
  • Experimental: Lab-Based Treatment: Active Stimulation, Then Sham Stimulation
    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.
  • Experimental: Lab-Based Treatment: Sham Stimulation, Then Active Stimulation
    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.

Primary Outcome Measure

For patients with post-stroke cognitive impairment--Stricker Learning Span and Symbols Test [ Time Frame: Baseline, 3 weeks, 12 weeks, 15 weeks, 24 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

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