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Procedure

TMS for Cervical Dystonia

N/A
Waitlist Available
Led By Noreen Bukhari-Parlakturk, MD PhD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 6 weeks post-dbs (visit 8), approximately 7 months (visit 9)

Summary

This trial aims to study how a specific type of brain stimulation called transcranial magnetic stimulation (TMS) can improve hand movement in patients with focal hand dystonia. The study will involve giving patients

Who is the study for?
This trial is for individuals with conditions like isolated focal hand dystonia, general dystonia, or torticollis. Participants should be able to attend 10 in-person visits and undergo MRI scans and behavior analysis. The study excludes those at risk of seizures or who don't meet the safety guidelines for TMS.
What is being tested?
The study tests whether four sessions of accelerated transcranial magnetic stimulation (TMS) can improve brain function and reduce symptoms in patients with focal hand dystonia. It includes fMRI brain scans before and after treatment to observe changes.
What are the potential side effects?
While TMS is generally safe, there's a small risk of seizures; however, this risk is minimized by strict adherence to safety protocols. Other possible side effects may include discomfort at the stimulation site or headache.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 6 weeks post-dbs (visit 8), approximately 7 months (visit 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 6 weeks post-dbs (visit 8), approximately 7 months (visit 9) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Neck Angles as Measured by Neck Sensor Device
Secondary study objectives
Behavioral Response After Deep Brain Stimulation (DBS), as measured by Neck Angles
Changes in Brain Activity (bold activity) on Functional Magnetic Resonance Imaging (fMRI)
Changes in Brain Activity (functional connectivity) on Functional Magnetic Resonance Imaging (fMRI)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: TMS to primary somatosensory cortexActive Control1 Intervention
Participants received TMS sessions at primary somatosensory cortex
Group II: sham TMSPlacebo Group1 Intervention
Participants receive sham TMS

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor
2,463 Previous Clinical Trials
2,981,810 Total Patients Enrolled
American Academy of NeurologyOTHER
11 Previous Clinical Trials
322 Total Patients Enrolled
1 Trials studying Torticollis
16 Patients Enrolled for Torticollis
Noreen Bukhari-Parlakturk, MD PhDPrincipal InvestigatorDuke Health
2 Previous Clinical Trials
32 Total Patients Enrolled
~33 spots leftby Jul 2029
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