Testing Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT07191327
- Status
- Recruiting
Conditions
- Posterior Cortical Atrophy
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- HD-tDCS sessions — DEVICEThis project translates decades of observational neuroimaging research into a biologically plausible stimulation target (i.e., DAN) and uses functional magnetic resonance imaging (fMRI) and positron emission tomography (PET) to plan personalized brain stimulation and to ensure target engagement. When available; those not MRI compatible will receive a standard montage with per channel amplitudes of up to 5 milliamperes (mA) or a montage derived from other imaging methods. Participants will receive 4 days of HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.
- Sham HD-tDCS sessions — DEVICEParticipants will receive 4 days of sham HD-tDCS sessions in person. During these sessions participants will have electrodes placed on different areas of the head and held in place with headgear. Participants may also have memory and thinking tests during and after the sessions as well as questionnaires about the experience. Additionally, on the fourth day participants may have repeat immersive virtual reality (iVR) as well as other study activities.
- HD-tDCS sessions - Open-label (after randomized treatment) — DEVICEOptional 26 weeks of additional HD-tDCS sessions. Participants can complete up to 5 days per week, but most people will complete about 3 days per week. The study team may also collect audio recordings of these sessions. Participants can complete this in person or at-home via using a secure, HIPAA-compliant videoconferencing with the supervision of a research staff member. Participant's that decide to complete the additional sessions at home, a research staff member will train a study partner during the first 4 HD-tDCS sessions in the office. This option may not be available or appropriate for all participants and the study team member will discuss this with participant's and study partners.
Study Details
This study is being completed to learn if high-definition transcranial direct current stimulation (HD-tDCS) has an effect on visual and thinking abilities in persons with posterior cortical atrophy (PCA). Participants will be randomized to receive real or sham HD-tDCS (8 sessions over 4 days). Following the randomized treatment, participants will have optional open-label phase with real HD-tDCS up to 26 weeks and other possible testing.
Key Dates
- Start date
- Jan 28, 2026
- Status verified
- Mar 2026
- Primary completion
- Sep 30, 2029
- Completion
- Sep 30, 2029
Study Design
- Enrollment
- 50 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Real stimulation - RandomizedFour consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.
- Sham Comparator: Sham stimulation - RandomizedFour consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.
- Experimental: Real stimulation - post randomized treatmentParticipants that agree to this will have up to 26 weeks of additional HD-tDCS sessions at home or in-person.
Primary Outcome Measure
Change in network connectivity measured via fMRI [ Time Frame: Baseline and Day 5 (after 4 days of HD-tDCS) ]
Central Contacts
- Stephen Schlaefflin, BS734-936-7360
- Eileen Robinson, RN-BC734-763-1356
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | Benjamin Hampstead, PhD (PRINCIPAL_INVESTIGATOR) |
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