kTMP in Chronic Stroke

NCT07277595 | Not Yet Recruiting DMC FDA Device

• 2 other identifiers: 25-43524R44NS139730
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment

  The Fugl-Meyer Assessment (FMA) is a structured evaluation used to measure motor recovery after a stroke, with a total score range of 0-226. Higher scores indicate better motor function, while lower scores reflect greater impairment.

  Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.

Secondary Outcomes (7)

• Wolf Motor Function Test

  At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

• Stroke Impact Scale

  At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

• Stroke Specific QOL

  At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

• EuroQOL

  At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

• Motor Activity Log

  At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

Active treatment with kTMP for 18 weeks

Device: kTMP 18 weeks

Crossover Treatment

OTHER

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

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

Interventions

kTMP 18 weeks DEVICE

Participants receive kTMP active stimulation for 18 weeks

Active Treatment

kTMP sham stimulation 9 weeks + active stimulation 9 weeks DEVICE

kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation

Crossover Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Karunesh Ganguly, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karunesh Ganguly, MD, PhD

CONTACT

415-514-1252; karunesh.ganguly@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 11, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): August 1, 2030
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)