kTMP in Chronic Stroke (KULMINATE)

University of California San Francisco (UCSF)

Status: Not yet enrolling

Conditions: Stroke; Arm Weakness as a Consequence of Stroke; Chronic Stroke Patients

Treatments: Device: kTMP 18 weeks; Device: kTMP sham stimulation 9 weeks + active stimulation 9 weeks

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07277595

25-43524

R44NS139730 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

kTMP, kilohertz transcutaneous magnetic perturbations, is a low intensity transcranial magnetic stimulation technique that will be used in this study to promote arm/hand rehabilitation in patients who have been disabled by stroke.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults age 18-80 years old who have had a stroke resulting in hemiplegia
• Ability to communicate, understand, and give appropriate consent
• Other criteria may apply

Exclusion criteria

• Significant cognitive impairment
• inability to adhere to the study protocol or provide informed consent
• pregnancy
• additional criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Active Treatment

Active Comparator group

Description:

Active treatment with kTMP for 18 weeks

Treatment:

Device: kTMP 18 weeks

Crossover Treatment

Other group

Description:

Initial 9 weeks will receive sham kTMP treatment, followed by 9 weeks of active kTMP treatment.

Treatment:

Device: kTMP sham stimulation 9 weeks + active stimulation 9 weeks