A clinical trial of focused ultrasound treatment for hand dystonia

Randomized controlled trial of focused ultrasound thalamotomy for focal hand dystonia - FUS-FHD RCT

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs032250448

Enrollment

Registered

2025-10-22

Start date

2025-10-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Focal hand dystonia Dystonia

Interventions

Subjects are randomly assigned to the treatment or sham group. The treatment group undergoes a single session of MR-guided focused ultrasound thalamotomy targeting the ventro-oral nucleus (MRgFUS Vo-t

focused ultrasound

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Men and women aged 18 to 70 years who score at least 2 points (moderate or greater disability) on at least one of the seven items of the Arm Dystonia Disability Scale (ADDS).

Exclusion criteria

Exclusion criteria: Subjects with a skull density ratio < 0.35, those unable to undergo MRI, those with severe cardiac disease or bleeding tendency, those with other neurodegenerative disorders, or those with significant cognitive impairment (MMSE < 24).

Design outcomes

Primary

Measure	Time frame
Change in Arm Dystonia Disability Scale (ADDS) score from baseline to 3 months, compared between the treatment and sham groups.	—

Secondary

Measure	Time frame
Between-group comparison of the change in scores on the Writers Cramp Rating Scale (WCRS) from baseline to 3 months after treatment Between-group comparison of changes in scores on the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and Apathy Evaluation Scale (AES) from baseline to 3 months after treatment Between-group comparison of changes in the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form 36 Health Survey (SF-36) from baseline to 3 months after treatment Between-group comparison of the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) scores at 3 months after treatment Evaluation of changes in scores on the Arm Dystonia Disability Scale (ADDS) and Writers Cramp Rating Scale (WCRS) from baseline to 6 months after treatment in all treated participants (including those initially assigned to the treatment group and those who crossed over from the sham group)	—

Measure

Time frame

Between-group comparison of the change in scores on the Writers Cramp Rating Scale (WCRS) from baseline to 3 months after treatment Between-group comparison of changes in scores on the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI), and Apathy Evaluation Scale (AES) from baseline to 3 months after treatment Between-group comparison of changes in the Physical Component Summary (PCS) and Mental Component Summary (MCS) scores of the Short Form 36 Health Survey (SF-36) from baseline to 3 months after treatment Between-group comparison of the Patient Global Impression of Change (PGIC) and Clinical Global Impression of Change (CGIC) scores at 3 months after treatment Evaluation of changes in scores on the Arm Dystonia Disability Scale (ADDS) and Writers Cramp Rating Scale (WCRS) from baseline to 6 months after treatment in all treated participants (including those initially assigned to the treatment group and those who crossed over from the sham group)

—

Countries

Japan, United States of America

Contacts

Public ContactAkiko Ueda

Tokyo Women's Medical University

carp-crb.bm@twmu.ac.jp+81-333538111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026