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

University of Michigan

Status: Enrolling

Conditions: Posterior Cortical Atrophy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07191327

HUM00268033

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• A recent (e.g., within the past 2 years) significant history of, or current, alcohol or drug abuse/dependence. Remote history of abuse/dependence is not exclusionary as long as it is not considered to be the primary etiology for visuospatial deficits.
• Women that are lactating/breastfeeding, pregnant, or may potentially be pregnant will be excluded from the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 3 patient groups

Real stimulation - Randomized

Experimental group

Description:

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

Treatment:

Device: HD-tDCS sessions

Sham stimulation - Randomized

Sham Comparator group

Description:

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

Treatment:

Device: Sham HD-tDCS sessions

Real stimulation - post randomized treatment

Experimental group

Description:

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

Treatment:

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