MRgFUS for Writer's Cramp
(FUS Dystonia Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Must not be taking: Anticoagulants, Antiplatelets
Disqualifiers: Generalized dystonia, Severe psychiatric disorder, Pregnancy, Severe hypertension, others
No Placebo Group
Approved in 2 Jurisdictions
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.
12345Is 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.
14567How 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.
89101112Eligibility 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
+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.
+13 more
Trial 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)
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Maryland Medical CenterBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
Focused Ultrasound FoundationCollaborator
InSightecIndustry Sponsor
References
Skull bone marrow injury caused by MR-guided focused ultrasound for cerebral functional procedures. [2019]One patient for whom an MR-guided focused ultrasound (MRgFUS) pallidotomy was attempted was discovered to have multiple new skull lesions with the appearance of infarcts on the MRI scan 3 months after his attempted treatment. The authors conducted a retrospective review of the first 30 patients treated with MRgFUS to determine the incidence of skull lesions in patients undergoing these procedures and to consider possible causes.
MRI-guided focused ultrasound thalamotomy in non-ET tremor syndromes. [2022]To report the 6-month single-blinded results of unilateral thalamotomy with MRI-guided focused ultrasound (MRgFUS) in patients with tremors other than essential tremor.
Magnetic Resonance-Guided Focused Ultrasound Thalamotomy May Spare Dopaminergic Therapy in Early-Stage Tremor-Dominant Parkinson's Disease: A Pilot Study. [2023]Magnetic resonance-guided focused ultrasound (MRgFUS) thalamotomy is a safe and effective procedure for drug-resistant tremor in Parkinson's disease (PD).
MR-guided focused ultrasound pallidotomy for Parkinson's disease: safety and feasibility. [2023]Stereotactic radiofrequency pallidotomy has demonstrated improvement in motor fluctuations in patients with Parkinson's disease (PD), particularly levodopa (L-dopa)-induced dyskinesias. The authors aimed to determine whether or not unilateral pallidotomy with MR-guided focused ultrasound (MRgFUS) could safely improve Unified Dyskinesia Rating Scale (UDysRS; the primary outcome measure) scores over baseline scores in patients with PD.
Functional tremor developing after successful MRI-guided focused ultrasound thalamotomy for essential tremor. [2022]To describe a case of functional tremor occurring after a successful MR-guided focused ultrasound thalamotomy (MRgFUS) for essential tremor.
The efficacy and limits of magnetic resonance-guided focused ultrasound pallidotomy for Parkinson's disease: a Phase I clinical trial. [2019]OBJECTIVERecently, MR-guided focused ultrasound (MRgFUS) has emerged as an innovative treatment for numerous neurological disorders, including essential tremor, Parkinson's disease (PD), and some psychiatric disorders. Thus, clinical applications with this modality have been tried using various targets. The purpose of this study was to determine the feasibility, initial effectiveness, and potential side effects of unilateral MRgFUS pallidotomy for the treatment of parkinsonian dyskinesia.METHODSA prospective, nonrandomized, single-arm clinical trial was conducted between December 2013 and May 2016 at a single tertiary medical center. Ten patients with medication-refractory, dyskinesia-dominant PD were enrolled. Participants underwent unilateral MRgFUS pallidotomy using the Exablate 4000 device (InSightec) after providing written informed consent. Patients were serially evaluated for motor improvement, neuropsychological effects, and adverse events according to the 1-year follow-up protocol. Primary measures included the changes in the Unified Parkinson's Disease Rating Scale (UPDRS) and Unified Dyskinesia Rating Scale (UDysRS) scores from baseline to 1 week, 1 month, 3 months, 6 months, and 1 year. Secondary measures consisted of neuropsychological batteries and quality of life questionnaire (SF-36). Technical failure and safety issues were also carefully assessed by monitoring all events during the study period.RESULTSUnilateral MRgFUS pallidotomy was successfully performed in 8 of 10 patients (80%), and patients were followed up for more than 6 months. Clinical outcomes showed significant improvements of 32.2% in the "medication-off" UPDRS part III score (p = 0.018) and 52.7% in UDysRS (p = 0.017) at the 6-month follow-up, as well as 39.1% (p = 0.046) and 42.7% (p = 0.046) at the 1-year follow-up, respectively. These results were accompanied by improvement in quality of life. Among 8 cases, 1 patient suffered an unusual side effect of sonication; however, no patient experienced persistent aftereffects.CONCLUSIONSIn the present study, which marks the first Phase I pilot study of unilateral MRgFUS pallidotomy for parkinsonian dyskinesia, the authors demonstrated the efficacy of pallidal lesioning using MRgFUS and certain limitations that are unavoidably associated with incomplete thermal lesioning due to technical issues. Further investigation and long-term follow-up are necessary to validate the use of MRgFUS in clinical practice.Clinical trial registration no.: NCT02003248 (clinicaltrials.gov).
Hemi-parkinsonism and return of essential tremors after MRgFUS thalamotomy: Case report and review of procedural complications affecting ventral thalamic nuclei. [2021]Magnetic resonance guided focused ultrasound (MRgFUS) thalamotomy targets the ventral intermediate nucleus of the thalamus and has been shown to be safe and effective to treat medication-resistant essential tremors. Improvement in tremor scores, posture and action scores, disability scores and quality of life scores have been reported in patients treated with this procedure. Adverse events are usually transient and non-severe. We present a patient who underwent MRgFUS thalamotomy of the left VIM and developed new-onset parkinsonian features predominantly on the right side and return of essential tremors a few years after the procedure. Changes in speech (hypophonia and dysarthria), gait imbalance and postural instability, bradykinesia, and cogwheeling rigidity occurred, likely due to involvement of the fiber tracts through the ventrolateral subnuclei and the adjacent ventral anterior thalamic nuclei and other surrounding structures. We describe side effects of MRgFUS thalamotomy in our patient compared to previous reports and review the thalamic nuclei and surrounding structures that can be affected during procedure, causing these effects.
Importance of awareness of the rhomboid lip in microvascular decompression surgery for hemifacial spasm. [2013]The authors adopted the infrafloccular approach for microvascular decompression (MVD) surgery to treat hemifacial spasm (HFS). The inferior portion of the flocculus is retracted to observe the root exit zone of cranial nerve (CN) VII between CN IX and the flocculus. During the procedure, the rhomboid lip, a sheetlike layer of neural tissue forming the lateral recess of the fourth ventricle, is sometimes encountered. The existence of the rhomboid lip in cases of HFS was reviewed to determine the importance of the structure during MVD surgery.
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]We analyzed factors associated with worsened paresis in a large series of patients with brain lesions located within or near the primary motor area (M1) to establish protocols for safe, awake craniotomy of eloquent lesions.
Magnetic resonance imaging and angiography in hemifacial spasm. [2019]We used magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) to investigate 14 patients with unilateral hemifacial spasm (HS) and 20 controls. The relationship of the seventh and eighth cranial nerves to adjacent vessels was best visualized on the contiguous flow sensitive 3D-FISP images. Reconstruction of projectional MRA was helpful to assess the complex architecture of the vertebrobasilar system. Neurovascular contact in the facial nerve root exit zone was present in 4 of 20 controls and in 12 of 14 patients, in whom it predicted the affected side. These results support previous findings of surgical and electrophysiological investigations that local irritation of the facial nerve is the most possible explanation for HS. MRI and MRA provide vascular and brain tissue diagnosis in a single non-invasive examination and should be recommended as primary neuroradiological procedure in HS.
A New Finding on Magnetic Resonance Imaging for Diagnosis of Hemifacial Spasm with High Accuracy and Interobserver Correlation. [2023]Among patients with clinical hemifacial spasm (HFS), imaging exams aim to identify the neurovascular conflict (NVC) location. It has been proven that the identification in the preoperative exam increases the rate of surgical success. Despite the description of specific magnetic resonance image (MRI) acquisitions, the site of neurovascular compression is not always visualized. The authors describe a new MRI finding that helps in the diagnosis of HFS, and evaluate the sensitivity, specificity, and interobserver correlation of the described sign. A cross-sectional study including cases of hemifacial spasm treated surgically from 1 August 2011 to 31 July 2021 was performed. The MRIs of the cases were independently evaluated by two experienced neuroradiologists, who were blinded regarding the side of the symptom. The neuroradiologists were assigned to evaluate the MRIs in two separate moments. Primarily, they evaluated whether there was a neurovascular conflict based on the standard technique. Following this initial analysis, the neuroradiologists received a file with the description of the novel sign, named Prevedello Sign (PS). In a second moment, the same neuroradiologists were asked to identify the presence of the PS and, if it was present, to report on which side. A total of 35 patients were included, mostly females (65.7%) with a mean age of 59.02 (+0.48). Since the 35 cases were independently evaluated by two neuroradiologists, a total of 70 reports were included in the analysis. The PS was present in 66 patients (sensitivity of 94.2%, specificity of 91.4% and positive predictive value of 90.9%). When both analyses were performed in parallel (standard plus PS), the sensitivity increased to 99.2%. Based on the findings of this study, the authors conclude that PS is helpful in determining the neurovascular conflict location in patients with HFS. Its presence, combined with the standard evaluation, increases the sensitivity of the MRI to over 99%, without increasing risks of harm to patients or resulting in additional costs.
[Microvascular decompression for hemifacial spasm: experience of 215 cases]. [2006]To investigate the relationship between pre-operational etiological diagnosis of medically intractable hemifacial spasm (HFS) and patterns of offending vessels and the curative effect of microvascular decompression (MVD).