University of Michigan
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Location contact
Benjamin Hampstead, PhD
PRINCIPAL_INVESTIGATOR
Eileen Robinson, RN-BC
CONTACT
Stephen Schlaefflin, BS
CONTACT
NCT Number: NCT07191327
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.
Interested in participating?
Request Info50 year and older
All sexes
Interventional
Not applicable
Ann Arbor, Michigan, 48109, United States
Location status: Recruiting
Benjamin Hampstead, PhD
PRINCIPAL_INVESTIGATOR
Eileen Robinson, RN-BC
CONTACT
Stephen Schlaefflin, BS
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
Time frame: Baseline and Day 5 (after 4 days of HD-tDCS)
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 at end of study intervention (up to 6 months)
This will evaluate dorsal and ventral visual stream functioning using a visual paradigm.
Time frame: Baseline and end of study intervention (up to 6 months)
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.
Time frame: Baseline and at end of study intervention (up to 6 months)
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)
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)
Form coherence is measured using a visual paradigm.
Time frame: Baseline and at end of study intervention (up to 6 months)
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)
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)
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)
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)
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)
Measured using standard fNIRS analysis
Time frame: Baseline and day 5 (after 4 days of HD-tDCS)
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)
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
Contact information is provided by the study sponsor or research team.
Eileen Robinson, RN-BC
CONTACT
Stephen Schlaefflin, BS
CONTACT
University of Michigan
Other
Testing Personalized High Definition Transcranial Direct Current Stimulation (HD-tDCS) as a Treatment of Posterior Cortical Atrophy
Acronym: PCA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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