BridgeMD
New treatment option for Task-Specific Focal Dystonia
Official title MRgFUS Pallidotomy for the Treatment of Task Specific Focal Hand Dystonia (TSFD)
ClinicalTrials.gov ID: NCT06367608
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 75
You may be able to join 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...
- Age greater than 21 and less than 75 years
- people who are able and willing to give consent and able to attend all study visits,
- Documented chronic, symptoms for more than 6 months duration
You likely can't join if
- Exclusion Criteria:
- 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...
- Life expectancy less than 12 months
- Anticoagulant or antiplatelet medications as well as underlying coagulopathy
See the full eligibility criteria
- 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
- people 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:
- 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
- people with unstable cardiac status such as unstable angina pectoris, documented myocardial infarction within 6 months of protocol entry or ejection fraction less than 40
- people 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)
- people 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.
- people 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.) \-
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.