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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment for task-specific focal hand dystonias (TSFD), which cause hand cramps during activities like writing or playing an instrument. The study uses MRI-guided focused ultrasound (MRgFUS) to target and treat a small brain area linked to these symptoms. The goal is to determine if this method is safe and effective. Individuals with moderate to severe TSFD who struggle with daily activities and haven't found relief with other treatments might be suitable candidates for this trial.

As an unphased trial, this study offers a unique opportunity to explore innovative treatment options for those seeking new solutions.

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 prior data suggests that MRgFUS Pallidotomy is safe for treating task specific focal hand dystonias?

Research has shown that MRI-guided focused ultrasound (MRgFUS) is becoming a safe way to treat dystonia, a condition causing involuntary muscle contractions. This method has been used for focal hand dystonia, such as writer's cramp, without major side effects. Studies have found that MRgFUS pallidotomy, which targets the globus pallidus internus in the brain, is well-tolerated. In one study, all 20 patients successfully completed the procedure, indicating its safety. Overall, MRgFUS appears to be a promising and safe option for those considering treatment for task-specific focal hand dystonias.12345

Why are researchers excited about this trial?

Researchers are excited about MRgFUS Pallidotomy for writer's cramp because it offers a unique, non-invasive approach to treatment. Unlike traditional therapies such as medications or botulinum toxin injections, this method uses focused ultrasound waves to precisely target and heat the globus pallidus internus (GPi) in the brain. This targeted approach aims to alleviate symptoms by disrupting the small cluster of cells believed to cause the condition. The use of ultrasound allows for a treatment that doesn't require surgery, potentially reducing recovery time and side effects.

What evidence suggests that MRgFUS Pallidotomy is effective for treating task specific focal hand dystonias?

Research has shown that MRI-guided focused ultrasound (MRgFUS) is a promising treatment for dystonia, including specific hand issues like writer's cramp. In this trial, participants will receive the ExAblate Transcranial treatment, which uses sound waves to target and heat a small part of the brain called the globus pallidus internus, aiding in movement control. Studies have found that MRgFUS can be safe and effective, reducing unwanted hand movements and cramps without major side effects. This non-surgical technique requires no cuts, making it less invasive. Early results suggest it could benefit those who struggle with involuntary hand movements during certain tasks.12567

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: ExAblate Transcranial treatmentExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as MRgFUS Pallidotomy for:
🇪🇺
Approved in European Union as MRgFUS Pallidotomy for:

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

Published Research Related to This Trial

This case study describes the first instance of a functional tremor developing in a 71-year-old man after a successful MR-guided focused ultrasound thalamotomy (MRgFUS) for essential tremor, highlighting a potential complication of this treatment.
Electrophysiological studies confirmed the presence of both essential tremor and a functional tremor, emphasizing the importance of recognizing such complications to prevent unnecessary additional treatments.
Functional tremor developing after successful MRI-guided focused ultrasound thalamotomy for essential tremor.Alshimemeri, S., Vargas-Méndez, D., Chen, R., et al.[2022]
In a study of 34 patients undergoing microvascular decompression (MVD) surgery for hemifacial spasm, the rhomboid lip was encountered in 26.5% of cases, indicating its significance during the procedure.
The rhomboid lip is rarely visible on preoperative MR images, but careful dissection during surgery is crucial to improve visualization of cranial nerve VII and prevent potential postoperative complications, such as dysphagia.
Importance of awareness of the rhomboid lip in microvascular decompression surgery for hemifacial spasm.Nakahara, Y., Matsushima, T., Hiraishi, T., et al.[2013]
In a study of 14 patients with unilateral hemifacial spasm (HS) and 20 controls, MRI and MRA revealed that neurovascular contact at the facial nerve root exit zone was significantly more common in patients (12 out of 14) compared to controls (4 out of 20), suggesting that this contact may be a key factor in causing HS.
The use of MRI and MRA as non-invasive diagnostic tools is recommended for evaluating hemifacial spasm, as they can effectively visualize the relationship between cranial nerves and adjacent blood vessels, supporting the hypothesis that local irritation of the facial nerve is a likely cause of the condition.
Magnetic resonance imaging and angiography in hemifacial spasm.Felber, S., Birbamer, G., Aichner, F., et al.[2019]

Citations

MRI-Guided Focused Ultrasound for the Treatment of DystoniaMRgFUS is an emerging modality that appears to be safe and effective, particularly in focal hand dystonia, without major adverse effects.
2.movementdisorders.onlinelibrary.wiley.commovementdisorders.onlinelibrary.wiley.com/doi/10.1002/mds.29811
Bilateral Simultaneous Magnetic Resonance–Guided ...Transcranial magnetic resonance–guided focused ultrasound (MRgFUS) is an emerging incisionless treatment for the ablation of brain structures.
MRgFUS Pallidotomy for the Treatment of Task Specific ...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 ( ...
MRI-Guided Focused Ultrasound in Parkinson's Disease and ...... MRgFUS ablation of the globus pallidus internus, MRgFUS pallidotomy is feasible and effective in the treatment of patients with PD and motor fluctuations ...
MR-Guided High Intensity Focused Ultrasound (MRgFUS) ...... MRgFUS ablation of the globus pallidus internus. RESULTS The sonication procedure was successfully completed in all 20 enrolled patients. MRgFUS ...
6.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33481557/
MR-guided focused ultrasound pallidotomy for Parkinson's ...This study supports the feasibility and preliminary efficacy of MRgFUS pallidotomy in the treatment of patients with PD and motor fluctuations, including ...
MRgFUS Pallidotomy for the Treatment of Task Specific ...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 ( ...
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