N/A N=12 Randomized Double-blind Basic Science

Neuromodulation Therapy for Task-Specific Dystonia

Isolated Focal Hand Dystonia

Bottom Line

View on ClinicalTrials.gov: NCT06422104 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions — 12; 12; 11 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Repetitive transcranial magnetic stimulation (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Jan 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility of Accurately Delivering TMS During the Task of Writing as Measured by Number of Participants Who Completed the TMS Sessions	12; 12; 11	—
SECONDARY Safety, as Measured by TMS Acute Side Effects	0; 0; 0	—
SECONDARY Change in Peak Accelerations Behavior (Calculated by Taking the Change in Peak Accelerations From Behavior Performed Before and After Each TMS Visit).	99.00; 96.43; 100.06	0.001 sig
SECONDARY Brain Connectivity Between Superior Parietal Cortex to Right Cerebellum VIII	0.28; 0.27; 0.44	0.048 sig

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.

Eligibility Criteria

Inclusion Criteria

Healthy Control Participants:
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
Focal Hand dystonia Patients:
18yrs and older
Left or Right hand dominance
Diagnosed with Writer's Cramp dystonia in left or right hand
Must be able to sign informed consent
Must be literate

Exclusion Criteria

Healthy Control Participants (visits 2, 3, 4, and 5) and Focal Hand dystonia Patients (visits 2, 3, 4, and 5):

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
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06422104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.