Neuromodulation Therapy for Task-Specific Dystonia (NCT06422104) | Clinical Trial Compass
CompletedNot Applicable
Neuromodulation Therapy for Task-Specific Dystonia
United States12 participantsStarted 2018-08-23
Plain-language summary
This study aims to apply a non-invasive brain stimulation technology called repetitive Transcranial Magnetic Stimulation (rTMS) in patients with focal hand dystonia (FHD). The goal of the study is to identify which cortical target (premotor cortex (PMC) or primary somatosensory cortex (PSC)) will show benefit after active rTMS compared to sham rTMS. A secondary goal of the study is to understand if 10 Hz rTMS can show behavioral benefit compared to sham rTMS. The study will evaluate rTMS response using measures if writing on a sensor tablet, examiner and patient dystonia rating scales and brain imaging scan (functional MRI) to understand brain changes after rTMS. Safety measures include adherence to TMS guidelines and thorough medical screening to prevent seizures.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 18yrs and older
✓. Left or Right hand dominance
✓. Age-matched to Focal Hand dystonia patients
✓. Must be able to sign informed consent
✓. Must be literate
✓. 18yrs and older
✓. Left or Right hand dominance
✓. Diagnosed with Writer's Cramp dystonia in left or right hand
Exclusion criteria
✕. Other neurological movement disorders diagnoses including other types of dystonia, Parkinsonism, or essential tremor
✕. Botulinum toxin injections within 3 months of research study
✕. Medications with effects on the central nervous system including anticholinergic, benzodiazepines, and muscle relaxants among others within 1 week of the study
What they're measuring
1
Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions
Timeframe: Pre-TMS and post-TMS session (each session is approximately 45 minutes)
✕. No physical or occupational therapy of the upper extremities
✕. Any contraindications to MRI (ie: metal in body or implanted medical devices, etc)
✕. Any contraindication on TMS adult safety screening (TASS form) including seizure history, pregnancy, brain injury, cranial metal implants, known structural brain lesion