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

N/ARecruitingNCT07191327

University of Michigan50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Posterior Cortical Atrophy

Interventions

HD-tDCS sessionsDEVICE

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.

Sham HD-tDCS sessionsDEVICE

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.

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

Time frame: 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.

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

Long-term change in network connectivity via fMRI

Time frame: 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.

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

Secondary Outcomes

Measures of motion tasks

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

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

Measure of form coherence tasks

Form coherence is measured using a visual paradigm.

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

Eye tracking - Number of fixations

The study team will quantify the number and duration of fixations, while the participants perform visual search, reading, or other visual tasks affected by PCA.

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

Eye tracking - Number of fixations

The study team will quantify the number and duration of fixations, while the participants perform visual search, reading, or other visual tasks affected by PCA.

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

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

The PCA-Q has 32 items and measures cognitive difficulty in 12 domains. It is reported as a composite score, with a lower overall score demonstrating less cognitive impairment.

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

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

The PCA-Q has 32 items and measures cognitive difficulty in 12 domains. It is reported as a composite score, with a lower overall score demonstrating less cognitive impairment

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

Immersive virtual reality (IVR) path length

Quotient of participants actual path length compared to the most efficient path length.

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

functional near infrared spectroscopy (fNIRS) - Activation magnitude of DAN (processed)

Measured using standard fNIRS analysis

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

Partner rating of cognitive change using the PCA-Q

The PCA-Q has 32 items and measures cognitive difficulty in 12 domains. It is reported as a composite score, with a lower overall score demonstrating less cognitive impairment

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

Partner rating of cognitive change using the PCA-Q

The PCA-Q has 32 items and measures cognitive difficulty in 12 domains. It is reported as a composite score, with a lower overall score demonstrating less cognitive impairment

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

Central Contacts

Stephen Schlaefflin, BS

CONTACT

734-936-7360 schlst@umich.edu

Eileen Robinson, RN-BC

CONTACT

734-763-1356 robinsoe@umich.edu

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts