A Study of Cerebral Perfusion with TDCS in Chronic Hypoperfusion

Mayo Clinic

Status: Invitation-only

Conditions: Moyamoya Disease; Atheroscleroses, Cerebral; Moyamoya Syndrome

Treatments: Behavioral: Cognitive training program; Device: Soterix® 4x1HD-TDCS; Device: Soterix® 1x1 tDCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06477107

24-001186

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

50 participants in 6 patient groups

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

Experimental group

Description:

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.

Treatment:

Device: Soterix® 4x1HD-TDCS

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

Experimental group

Description:

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.

Treatment:

Device: Soterix® 4x1HD-TDCS

Phase I Disease Group: Active Stimulation, Then Sham Stimulation

Experimental group

Description:

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.

Treatment:

Device: Soterix® 4x1HD-TDCS

Phase I Disease Group: Sham Stimulation, Then Active Stimulation

Experimental group

Description:

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.

Treatment:

Device: Soterix® 4x1HD-TDCS

Phase II Active Stimulation, Then Sham Stimulation

Experimental group

Description:

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.

Treatment:

Device: Soterix® 1x1 tDCS

Behavioral: Cognitive training program

Phase II Sham Stimulation, Then Active Stimulation

Experimental group

Description:

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.

Treatment:

Device: Soterix® 1x1 tDCS

Behavioral: Cognitive training program