RECRUITING

Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. Those patients with a previous intervention, must have a prior diagnosis of ET, cerebellar outflow tremor, or MS-related tremor. Subjects without a previous intervention must have a diagnosis of cerebellar outflow tremor or MS-related tremor.

Official Title

Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor

Quick Facts

Study Start:2025-05-19

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07049003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 cerebellar outflow or MS-related tremor. * 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 to MRI contrast agent; * 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 to consent.); * 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;

Inclusion Criteria

Exclusion 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 cerebellar outflow or MS-related tremor.
* 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 to MRI contrast agent;
* 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 to consent.);
* 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;

Contacts and Locations

Study Contact

Jeffrey Negrey, MA

CONTACT

2163166896

negreyj2@ccf.org

Study Locations (Sites)

Cleveland Clinic

Cleveland, Ohio, 44195

United States

Collaborators and Investigators

Sponsor: The Cleveland Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-19

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2025-05-19

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Tremor
Essential Tremor