Testing Personalized High-Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy

NCT07191327 | Recruiting FDA Device

• 1 other identifier: HUM00268033
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Posterior Cortical Atrophy

Keywords

HD-tDCS; Functional Magnetic resonance imaging (fMRI); Positron emission tomography/computerized tomography; Memory and thinking testing; Computerized tests; Questionnaires; Blood draws; Eye tracking and vision tests; Functional Near Infrared Spectroscopy

Outcome Measures

Primary Outcomes (4)

• Change in network connectivity measured via fMRI

  Functional connectivity measures whether activity in different brain regions show similar patterns of change over time. Graph theory metrics of resting-state fMRI can characterize functional connectivity within the Dorsal Attention Network (DAN).

  Baseline and Day 5 (after 4 days of HD-tDCS)

• Measure of form coherence

  This will evaluate dorsal and ventral visual stream functioning using a visual paradigm.

  Baseline and at end of study intervention (up to 6 months)

• Long-term change in network connectivity via fMRI

  Functional connectivity measures whether activity in different brain regions show similar patterns of change over time. Graph theory metrics of resting-state fMRI can characterize functional connectivity within the Dorsal Attention Network.

  Baseline and end of study intervention (up to 6 months)

• Measures of motion tasks

  This will evaluate dorsal and ventral visual stream function. Motion coherence is measured using a visual paradigm.

  Baseline and at end of study intervention (up to 6 months)

Secondary Outcomes (10)

• Measures of motion tasks

  Baseline and day 5 (after 4 days of HD-tDCS)

• Measure of form coherence tasks

  Baseline and day 5 (after 4 days of HD-tDCS)

• Eye tracking - Number of fixations

  Baseline and at end of study intervention (up to 6 months)

• Eye tracking - Number of fixations

  Baseline and day 5 (after 4 days of HD-tDCS)

• Self-ratings of cognitive change using the Posterior Cortical Atrophy Questionnaire (PCA-Q)

  Baseline and day 5 (after 4 days of HD-tDCS)

Study Arms (3)

Real stimulation - Randomized

EXPERIMENTAL

Four consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.

Device: HD-tDCS sessions

Sham stimulation - Randomized

SHAM COMPARATOR

Four consecutive days (2 sessions for 20 minutes each day for a total of 8 sessions) of this blinded stimulation.

Device: Sham HD-tDCS sessions

Real stimulation - post randomized treatment

EXPERIMENTAL

Participants that agree to this will have up to 26 weeks of additional HD-tDCS sessions at home or in-person.

Device: HD-tDCS sessions - Open-label (after randomized treatment)

Interventions

HD-tDCS sessions DEVICE

This 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.

Real stimulation - Randomized

Sham HD-tDCS sessions DEVICE

Participants 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.

Sham stimulation - Randomized

HD-tDCS sessions - Open-label (after randomized treatment) DEVICE

Optional 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.

Real stimulation - post randomized treatment

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis or symptoms consistent with PCA
• Fluent in English
• HD-tDCS compatible
• Stable on relevant medications for at least approximately 4 weeks prior to study enrollment
• If completing any additional, optional, long-term study visits in a remote location (i.e., not our office), a study partner is required in order to administer HD-tDCS. Those choosing to return to our office may have, but are not required to have, a study partner.

You may not qualify if:

• Other relevant neurological disease (e.g., epilepsy) or injuries (e.g., large vessel stroke, moderate-severe traumatic brain injury) viewed as primary to deficits since these could interfere with etiologic considerations and confound study results
• Active, relevant psychiatric conditions (e.g., bipolar disorder, schizophrenia) since the symptoms of these conditions may confound study participation.
• Women that are lactating/breastfeeding, pregnant, or may potentially be pregnant will be excluded from the study.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

Study Officials

• Benjamin Hamstead, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephen Schlaefflin, BS

CONTACT

734-936-7360; schlst@umich.edu

Eileen Robinson, RN-BC

CONTACT

734-763-1356; robinsoe@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized first 4 days of treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomized to receive sham (fake) or real stimulation for the first 4 days of HD-tDCS After the first 4 days, if participants choose to continue to be in the study, all participants will receive "real" stimulation for up to 26 weeks.

Study Record Dates

• First Submitted: September 17, 2025
• First Posted: September 24, 2025
• Study Start: January 28, 2026
• Primary Completion (Estimated): September 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Study data will be available for sharing at the time manuscripts are published or when the grant ends, whichever is sooner. The data will be retained in Deep Blue for at least 10 years, after which it will be reviewed for continued preservation by the University Library personnel.

Locations

US (1)