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A Study of Cerebral Perfusion with TDCS in Chronic Hypoperfusion

NCT ID: NCT06477107

Last Updated: 2024-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-24

Study Completion Date

2026-06-30

Brief Summary

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This study is being done to examine whether transcranial direct current stimulation (tDCS) will increase cerebral blood flow which may provide a clinical benefit such as improving cognitive impairment.

Detailed Description

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Conditions

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Moyamoya Syndrome Moyamoya Disease Atheroscleroses, Cerebral

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

For the Phase I portion of the study subjects the order of the stimulation (active vs sham stimulation) in a single session will be randomized and counterbalanced across subjects.

For the Phase II portion of the study a cross-over design will be used and the subjects will be randomly assigned either to active or sham tDCS first, then they will cross over to the other treatment arm after 4-week period of washout.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Phase I - Health Volunteer Group: Active Stimulation, Then Sham Stimulation

Healthy subjects will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group Type EXPERIMENTAL

Soterix® 4x1HD-TDCS

Intervention Type DEVICE

Is intended for inducing cortical neuromodulation for research and treatment purposes.

Phase I - Health Volunteer Group: Sham Stimulation, Then Active Stimulation

Healthy subjects will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group Type EXPERIMENTAL

Soterix® 4x1HD-TDCS

Intervention Type DEVICE

Is intended for inducing cortical neuromodulation for research and treatment purposes.

Phase I Disease Group: Active Stimulation, Then Sham Stimulation

Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive 20 minutes of 2 mA tDCS concurrently with MRI cerebral blood flow (CBF) imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive sham stimulation concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group Type EXPERIMENTAL

Soterix® 4x1HD-TDCS

Intervention Type DEVICE

Is intended for inducing cortical neuromodulation for research and treatment purposes.

Phase I Disease Group: Sham Stimulation, Then Active Stimulation

Subject diagnosed with Moyamoya disease or severe extracranial atherosclerotic disease will receive sham stimulation concurrently with MRI CBF imaging immediately followed by no stimulation and CBF imaging. Next, subjects will receive 20 minutes of 2 mA tDCS concurrently with CBF imaging immediately followed by no stimulation and CBF imaging.

Group Type EXPERIMENTAL

Soterix® 4x1HD-TDCS

Intervention Type DEVICE

Is intended for inducing cortical neuromodulation for research and treatment purposes.

Phase II Active Stimulation, Then Sham Stimulation

Subjects first receive active tDCS plus cognitive training every weekday for 10 days. After washout period of 4 weeks, they will perform at-home sham tDCS plus cognitive training every weekday for 10 days.

Group Type EXPERIMENTAL

Soterix® 1x1 tDCS

Intervention Type DEVICE

At-home remotely supervised transcranial direct current stimulation (tDCS) at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and automatic turn off once it reaches the maximal intensity.

Cognitive training program

Intervention Type BEHAVIORAL

Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation

Phase II Sham Stimulation, Then Active Stimulation

Subjects first receive sham tDCS plus cognitive training daily for 10 days. After a washout period of 4 weeks, they will perform at-home active tDCS plus cognitive training daily for 10 days.

Group Type EXPERIMENTAL

Soterix® 1x1 tDCS

Intervention Type DEVICE

At-home remotely supervised transcranial direct current stimulation (tDCS) at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and automatic turn off once it reaches the maximal intensity.

Cognitive training program

Intervention Type BEHAVIORAL

Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation

Interventions

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Soterix® 4x1HD-TDCS

Is intended for inducing cortical neuromodulation for research and treatment purposes.

Intervention Type DEVICE

Soterix® 1x1 tDCS

At-home remotely supervised transcranial direct current stimulation (tDCS) at an intensity of 2 mA for 20 minutes per session, with slow ramp-up and automatic turn off once it reaches the maximal intensity.

Intervention Type DEVICE

Cognitive training program

Computerized cognitive therapy for 45 minutes per day that starts at the same time with stimulation

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Vasculopathy leading to imaging evidence of hypoperfusion
* Cognitive impairment

Exclusion Criteria

* Pregnancy
* Contraindication to MRI or tDCS including metallic implanted objects.
* Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Zafer Keser

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zafer Keser

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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24-001186

Identifier Type: -

Identifier Source: org_study_id