10 Participants Needed

MRgFUS for Writer's Cramp

(FUS Dystonia Trial)

DG
KH
NH
Overseen ByNajme Hosseini
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are on anticoagulant or antiplatelet medications.

What data supports the effectiveness of the treatment MRgFUS Pallidotomy for Writer's Cramp?

MR-guided focused ultrasound (MRgFUS) has been shown to be a safe and effective treatment for reducing tremors in conditions like Parkinson's disease and essential tremor, suggesting it may also help with similar movement disorders like Writer's Cramp.12345

Is MR-guided focused ultrasound (MRgFUS) generally safe for humans?

MR-guided focused ultrasound (MRgFUS) has been used in treatments for conditions like Parkinson's disease and essential tremor. Some studies report that it is generally safe, but there have been cases of side effects such as skull lesions, functional tremors, and temporary adverse events. More research and long-term follow-up are needed to fully understand its safety.14567

How is MRgFUS Pallidotomy treatment different from other treatments for Writer's Cramp?

MRgFUS Pallidotomy is unique because it uses focused ultrasound waves guided by MRI to target and destroy specific brain tissue without the need for invasive surgery, offering a non-invasive alternative to traditional surgical methods.89101112

Eligibility Criteria

This trial is for individuals with task specific focal hand dystonias (TSFD), which causes involuntary movements or cramping of the hands during activities like writing or playing instruments. Participants must meet certain health criteria to be eligible.

Inclusion Criteria

I am between 22 and 74 years old.
I have had symptoms for more than 6 months.
Pallidotomy is feasible based on evaluation of imaging studies
See 5 more

Exclusion Criteria

Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI
Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
I have muscle contractions affecting multiple body areas.
See 13 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo MR guided focused ultrasound thalamotomy targeting the globus pallidus internus (GPi) using the ExAblate Transcranial system

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments including adverse events and changes in dystonia intensity and quality of life

6 months
Multiple visits (in-person and virtual)

Treatment Details

Interventions

  • MRgFUS Pallidotomy
Trial Overview The study is testing the safety and effectiveness of a non-invasive procedure called MRgFUS Pallidotomy, which uses MRI-guided focused ultrasound to target brain areas involved in TSFD.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: ExAblate Transcranial treatmentExperimental Treatment1 Intervention
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.

MRgFUS Pallidotomy is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as MRgFUS Pallidotomy for:
  • Parkinson's disease
  • Essential tremor
  • Dyskinesias
  • Task specific focal hand dystonias (TSFD)
🇪🇺
Approved in European Union as MRgFUS Pallidotomy for:
  • Parkinson's disease
  • Essential tremor
  • Dyskinesias

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Maryland, Baltimore

Lead Sponsor

Trials
729
Recruited
540,000+

Focused Ultrasound Foundation

Collaborator

Trials
18
Recruited
460+

InSightec

Industry Sponsor

Trials
92
Recruited
3,800+

Dr. Maurice R. Ferré

InSightec

Chief Executive Officer

MD

Dr. Arjun Desai

InSightec

Chief Medical Officer

MD

Findings from Research

In a study of 30 patients treated with MR-guided focused ultrasound (MRgFUS) for movement disorders, 7 patients developed new skull lesions after treatment, although all were asymptomatic and lesions were not visible immediately after the procedure.
The study found that higher energy levels applied during the MRgFUS procedure were associated with the development of skull lesions, suggesting that local skull properties may influence the risk of such lesions, warranting further investigation.
Skull bone marrow injury caused by MR-guided focused ultrasound for cerebral functional procedures.Schwartz, ML., Yeung, R., Huang, Y., et al.[2019]
In a study involving 6 patients with various types of tremors, MRI-guided focused ultrasound (MRgFUS) targeting the ventro-intermedius nucleus (Vim) resulted in a significant reduction in tremor scores, with improvements sustained for up to 6 months.
While MRgFUS is a promising incision-free treatment for tremors other than essential tremor, some patients experienced transient and persistent side effects, highlighting the need for further research on its safety and effectiveness.
MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes.Fasano, A., Llinas, M., Munhoz, RP., et al.[2022]
In a study involving 10 patients with early-stage tremor-dominant Parkinson's disease who underwent MRgFUS thalamotomy, the procedure was found to effectively reduce tremors without the need to increase dopaminergic medication over 6 months.
In contrast, a control group of 20 patients on standard dopaminergic therapy showed a significant increase in their medication dosage, highlighting the potential of MRgFUS as a beneficial alternative treatment.
Magnetic Resonance-Guided Focused Ultrasound Thalamotomy May Spare Dopaminergic Therapy in Early-Stage Tremor-Dominant Parkinson's Disease: A Pilot Study.Golfrè Andreasi, N., Cilia, R., Romito, LM., et al.[2023]

References

Skull bone marrow injury caused by MR-guided focused ultrasound for cerebral functional procedures. [2019]
MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. [2022]
Magnetic Resonance-Guided Focused Ultrasound Thalamotomy May Spare Dopaminergic Therapy in Early-Stage Tremor-Dominant Parkinson's Disease: A Pilot Study. [2023]
MR-guided focused ultrasound pallidotomy for Parkinson's disease: safety and feasibility. [2023]
Functional tremor developing after successful MRI-guided focused ultrasound thalamotomy for essential tremor. [2022]
The efficacy and limits of magnetic resonance-guided focused ultrasound pallidotomy for Parkinson's disease: a Phase I clinical trial. [2019]
Hemi-parkinsonism and return of essential tremors after MRgFUS thalamotomy: Case report and review of procedural complications affecting ventral thalamic nuclei. [2021]
Importance of awareness of the rhomboid lip in microvascular decompression surgery for hemifacial spasm. [2013]
Awake craniotomy for brain lesions within and near the primary motor area: A retrospective analysis of factors associated with worsened paresis in 102 consecutive patients. [2022]
Magnetic resonance imaging and angiography in hemifacial spasm. [2019]
A New Finding on Magnetic Resonance Imaging for Diagnosis of Hemifacial Spasm with High Accuracy and Interobserver Correlation. [2023]
[Microvascular decompression for hemifacial spasm: experience of 215 cases]. [2006]
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