MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)

NCT06367608 | Recruiting DMC FDA Device

• 1 other identifier: HP-00104695
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Task-Specific Focal Dystonia

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment related adverse events

  Procedure related or device related adverse events will be reported, from the treatment day through the 6-month follow-up period.

  All events will be reported up to 6 months from treatment

Secondary Outcomes (3)

• Change in dystonia intensity

  6 Months

• Change in patient's perception of quality of life

  6 months

• Change in patient's perception of the effect of the procedure

  6 Months

Study Arms (1)

ExAblate Transcranial treatment

EXPERIMENTAL

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.

Device: ExAblate Transcranial treatment

Interventions

ExAblate Transcranial treatment DEVICE

The ExAblate Transcranial system will be used to destroy a small cluster of cells that may be causing the study participant's dystonia . 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.

Also known as: The ExAblate® MR guided focused ultrasound system

ExAblate Transcranial treatment

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
• Presence of generalized dystonia or involvement of two or more contiguous body regions (such as Arm along with neck)
• Severe psychiatric disorder such as uncontrolled depression, anxiety, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
• Life expectancy less than 12 months
• Anticoagulant or antiplatelet medications as well as underlying coagulopathy
• Pregnant ladies or women of childbearing age who are sexually active and not using contraception
• Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
• Presence of intracranial mass or an acute intracranial abnormality
• Subjects with unstable cardiac status such as unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry or ejection fraction less than 40
• Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV)
• Severe hypertension (diastolic blood pressure \> 100 on medication or persistently elevated systolic blood pressure\>140 mmHg despite adequate antihypertensive medications)
• History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
• Cerebrovascular disease (multiple cerebrovascular accident's (CVA) or CVA within 6 months)
• Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.
• Subjects with a history of seizures within the past year

Sponsors & Collaborators

• University of Maryland, Baltimore: lead
• Focused Ultrasound Foundation: collaborator
• InSightec: collaborator

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Dystonia, Focal, Task-Specific

Central Study Contacts

Dheeraj Gandhi, MD

CONTACT

(248)-497-8856; dgandhi@umm.edu

Najme Hosseini

CONTACT

410-328-4068; NHosseini@som.umaryland.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 16, 2024
• Study Start: June 10, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)