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Not yet recruiting NCT07277595

kTMP in Chronic Stroke

No phase Interventional Stroke Chronic Stroke Patients Arm Weakness as a Consequence of Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: kTMP sham stimulation 9 weeks + active stimulation 9 weeks, kTMP 18 weeks.
Who it may be relevant to
Registry conditions: Stroke, Chronic Stroke Patients, Arm Weakness as a Consequence of Stroke. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

KTMP: A Novel Method of Non-invasive Brain Stimulation to Enhance Motor Function in Chronic Stroke Patients.

Overview

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.

Interventions

  • Device kTMP sham stimulation 9 weeks + active stimulation 9 weeks
    kTMP 9 weeks sham-kTMP stimulation, followed by 9 weeks active kTMP stimulation
  • Device kTMP 18 weeks
    Participants receive kTMP active stimulation for 18 weeks

Primary outcome measures

  • Fugl Meyer Assessment [Time frame: Enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34.]
Secondary outcome measures (7)
  • Wolf Motor Function Test [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]
  • Stroke Impact Scale [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]
  • Stroke Specific QOL [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]
  • EuroQOL [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]
  • Motor Activity Log [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]
  • Modified Ashworth Scale Scores [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]
  • Action Research Arm Test [Time frame: At enrollment, then weeks 3, 6, 9, 12, 15, 18, and 34]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • University of California, San Francisco — San Francisco

Identifiers

NCT: NCT07277595 · 25-43524 · R44NS139730

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗