What this study is
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.
What's being tested
- ExAblate Transcranial treatment
Intervention · 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
- Official title
- Phase 1 Clinical Trial for MR Guided Focused Ultrasound (FUS) Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
- Sponsor
- University of Maryland, Baltimore
- Conditions
- Task-Specific Focal Dystonia
- Enrolling
- 10 people
- Starts
- 2024-06-10
- Est. completion
- 2028-06
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 21 Years – 75 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- Clinical diagnosis of moderate to severe TSFD with impact in their daily function or occupation function
- Patients who failed to response or had unsatisfactory response to the first treatment, such as Botulinum toxin treatment or DBS or refuse these alternative options
- Age greater than 21 and less than 75 years
- Subjects who are able and willing to give consent and able to attend all study visits,
- Documented chronic, symptoms for more than 6 months duration
- Pallidotomy is feasible based on evaluation of imaging studies
- Patient able to communicate sensations during the ExAblate TcMRgFUS treatment
- Two members of the medical team have agreed upon inclusion and exclusion criteria
You can't join if
- Patient with contraindications to MRI such as severe claustrophobia and metallic implants incompatible with MRI.
- Presence of generalized dystonia or involvement of two or more contiguous body regions (such as Arm along with neck)
- Severe psychiatric disorder such as uncontrolled depression, anxiety, bipolar disorder, prior attempt at suicide or suicide ideation in preceding 12 months
- Life expectancy less than 12 months
- Anticoagulant or antiplatelet medications as well as underlying coagulopathy
- Pregnant ladies or women of childbearing age who are sexually active and not using contraception
- Inability to provide informed consent, for example due to underlying cognitive impairment or aphasia
- Presence of intracranial mass or an acute intracranial abnormality
- Subjects with unstable cardiac status such as unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry or ejection fraction less than 40
- Subjects exhibiting any behavior(s) consistent with ethanol or substance abuse as defined by the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders(DSM-IV)
- Severe hypertension (diastolic blood pressure > 100 on medication or persistently elevated systolic blood pressure>140 mmHg despite adequate antihypertensive medications)
- History of intracranial hemorrhage, traumatic brain injury or thalamic stroke.
- Cerebrovascular disease (multiple cerebrovascular accident's (CVA) or CVA within 6 months)
- Subjects with life-threatening systemic disease that include and not limited to the following will be excluded from the study participation: HIV, Liver Failure, blood dyscrasias, etc.
- Subjects with a history of seizures within the past year
- Individuals who are not able or willing to tolerate the required prolonged stationary supine position during treatment (can be up to 4 hours of total table time.) -
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
Loading treatment details…
Study locations (1)
1 openUniversity of Maryland Medical Center
Baltimore, Maryland, United States
- Najme Hosseini · Contact410-328-4068NHosseini@som.umaryland.edu
- Kaitlyn Henry, MS · Contact410-328-0939khenry@som.umaryland.edu
Recruiting
Study team
Sponsor
University of Maryland, Baltimore
Study ID HP-00104695
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.