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

Conditions

• Task-Specific Focal Dystonia

Eligibility Criteria

Sex

ALL

Age

21 Years - 75 Years

Healthy Volunteers

Not accepted

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.

Study Details

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.

Key Dates

Start date

Jun 10, 2024

Status verified

Feb 2026

Primary completion

Jun 30, 2027

Completion

Jun 30, 2028

Study Design

Enrollment

10 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• 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.

Primary Outcome Measure

Incidence of Treatment related adverse events [ Time Frame: All events will be reported up to 6 months from treatment ]

Central Contacts

• Dheeraj Gandhi, MD
  (248)-497-8856
  [email protected]
• Najme Hosseini
  410-328-4068
  [email protected]

Locations (1)

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