Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this study is to assess the safety and effectiveness of MRI-guided focused ultrasound (MRgFUS) for treating task specific focal hand dystonias (TSFD). TSFD is a type of dystonia that affects hand movements during specific tasks such as writing, playing instruments or typing, often causing involuntarily movements or cramping.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 75
Healthy Volunteers: f
View:

• Clinical diagnosis of moderate to severe TSFD with impact in their daily function or occupation function

• Patients who failed to response or had unsatisfactory response to the first treatment, such as Botulinum toxin treatment or DBS or refuse these alternative options

• Age greater than 21 and less than 75 years

• Subjects who are able and willing to give consent and able to attend all study visits,

• Documented chronic, symptoms for more than 6 months duration

• Pallidotomy is feasible based on evaluation of imaging studies

• Patient able to communicate sensations during the ExAblate TcMRgFUS treatment

• Two members of the medical team have agreed upon inclusion and exclusion criteria

Locations
United States
Maryland
University of Maryland Medical Center
RECRUITING
Baltimore
Contact Information
Primary
Dheeraj Gandhi, MD
dgandhi@umm.edu
(248)-497-8856
Backup
Najme Hosseini
NHosseini@som.umaryland.edu
410-328-4068
Time Frame
Start Date: 2024-06-10
Estimated Completion Date: 2028-06
Participants
Target number of participants: 10
Treatments
Experimental: ExAblate Transcranial treatment
The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's pain . The ExAblate uses ultrasound to heat a small spot in the brain called globus pallidus internus(GPi). Ultrasound passes through the skin and skull and into the brain to focus on this particular spot.
Sponsors
Collaborators: InSightec, Focused Ultrasound Foundation
Leads: University of Maryland, Baltimore

This content was sourced from clinicaltrials.gov

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