A Phase 1 interventional study of Transcranial Magnetic Stimulation and Sham Magnetic Stimulation in Hemiparesis, Neonatal Stroke and Ischemic Stroke, sponsored by Nationwide Children's Hospital. Completed at 2 sites in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-04-01.
Sponsored by Nationwide Children's Hospital · Phase 1, Interventional, and Treatment
This is a pilot study of repetitive transcranial magnetic stimulation (rTMS) to test tolerance and efficacy in children who have hemiparesis from acquired or presumed perinatal stroke.
The investigators will begin to test the hypothesis that rTMS will be tolerated and will result in improved hand strength and mobility when compared with sham stimulation.
Aim 1: To determine whether 1 Hz rTMS applied to the hemisphere opposite the infarct (contralesional or healthy hemisphere) is tolerated by children ages 6-18 years who have chronic motor sequelae from a stroke.
Aim 2: To determine whether 8 sessions of inhibitory 1 Hz rTMS to the contralesional healthy hemisphere improves grip strength and hand mobility when compared with sham stimulation in controls.
Exclusion Criteria:
Active Magnetic Stimulation with repetitive transcranial magnetic stimulation
Device: Transcranial Magnetic Stimulation
Sham Magnetic Stimulation
Device: Sham Magnetic Stimulation
Transcranial Magnetic Stimulation, repetitive at 1Hz
Also known as: MagStim
Sham Magnetic Stimulation
Also known as: MagStim
Tolerance to repetitive stimulation
The patient's reports of side effects recorded on the CRF at each session will be tabulated and the pre-stimulation scores will be subtracted from the post-stimulation scores. Cognitive function will be assessed with 6 measures (Executive Function / Spatial Problem Solving, Psychomotor Function / Speed of Processing, Visual Attention / Vigilance, Visual Learning \& Memory, Verbal Learning \& Memory, and Attention / Working Memory measures). As with the tolerance assessments, we will tabulate before-stimulation and after-stimulation assessments and analyze the difference.
Time frame: Up to 2 days
Upper extremity strength and mobility
Upper extremity strength will be assessed with a Jtech dynamometer at three different locations: elbow extension (triceps), elbow flexion (biceps), and grip. Joint mobility at the elbow and wrist will be assessed with the modified Ashworth score.
Time frame: Up to 2 Months
This study is completed, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Nationwide Children's Hospital