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New treatment option for Tremor
Official title Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
ClinicalTrials.gov ID: NCT07049003
What this study is testing
- What it's testing
- This objective of this study is to document the safety and feasibility of electrical stimulation of the deep cerebellar nuclei for refractory tremor using the Medtronic Percept RC Deep Brain Stimulation System. The population will consist of patients that have either failed a prior intervention (Vim DBS or HIFU thalamotomy) or determined to not be suitable candidates for Vim DBS or HIFU thalamotomy because they have a cerebellar outflow or MS-related tremor.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- Age 21 years and older;
- Ability to give informed consent;
- Diagnosis of ET, cerebellar tremor, or MS-related tremor with a failed a prior intervention (VIM DBS or HIFU thalamotomy) or determined to not be...
- Tremor history of at least three years;
- Tremor that is refractory to medical management;
You likely can't join if
- Any other neurological condition that could reduce the safety of study participation including central nervous system vasculitis and intracranial...
- A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or...
- A diagnosis of dementia;
- Tremors due to other neurological conditions such as Parkinson's disease, dystonia, or other conditions not consistent with ET, cerebellar outflow...
- Diagnosis of epilepsy;
- Major active and untreated psychiatric illness that may interfere with study, such as psychotic disorders or severe personality disorders;
See the full eligibility criteria
- Age 21 years and older;
- Ability to give informed consent;
- Diagnosis of ET, cerebellar tremor, or MS-related tremor with a failed a prior intervention (VIM DBS or HIFU thalamotomy) or determined to not be suitable candidates for VIM DBS or HIFU thalamotomy because they have a...
- Tremor history of at least three years;
- Tremor that is refractory to medical management;
- A score of ≥24 on the Mini Mental State Examination;
- Inability to successfully perform ADLs without assistance or has lost interest in social, professional, or personal activities due to tremor
- Any other neurological condition that could reduce the safety of study participation including central nervous system vasculitis and intracranial malignancy
- A condition that, in the opinion of the clinical investigator, would significantly increase the risk or interfere with study compliance, safety, or outcome;
- A diagnosis of dementia;
- Tremors due to other neurological conditions such as Parkinson's disease, dystonia, or other conditions not consistent with ET, cerebellar outflow tremor, or MS-related tremor.
- Diagnosis of epilepsy;
- Major active and untreated psychiatric illness that may interfere with study, such as psychotic disorders or severe personality disorders;
- Untreated or inadequately treated depression defined by a score of 20 or greater on the Beck Depression Inventory-II at the time of enrollment;
- At risk for suicide defined by a score greater or equal to 3 on the Columbia Suicide Severity Rating Scale (C-SSRS);
- Pregnancy;
- Unable to communicate with investigators or staff;
- Surgical contraindications to DN DBS;
- Contraindication to magnetic resonance (MRI) imaging, e.g., weight incompatible with scanner, implanted metallic devices or electrical devices (pacemaker, defibrillator, spinal cord stimulator, prior DBS) or intolerance...
- Enrolled in another device, biologic or pharmaceutical study within 30 days of consent in the current study, (i.e., patient cannot be enrolled if participation in another study was not completed at least 30 days prior...
- Evidence of behavior(s) consistent with alcohol or substance abuse/dependence as defined by the criteria outlined in the DSM-V within the preceding six months;
- Injection of botulinum toxins into the arm, neck or face within six months prior to baseline;
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, 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.