Cleveland Clinic
Cleveland, Ohio, 44195, United States
Location status: Recruiting
NCT Number: NCT07049003
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.
Interested in participating?
Request Info21 year and older
All sexes
Interventional
Phase 1
Cleveland, Ohio, 44195, United States
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Deep Brain Stimulation of the Deep Cerebellar Nuclei
Other names: Medtronic Percept DBS System
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
The accumulation of adverse events across all subjects
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
An objective measurement of the severity of tremor. A 32-part questionnaire that evaluates tremor severity by assigning a numerical value of 0-4 to the answers for 32 questions. Numerical values are added together for a total score. A higher score represents a more severe tremor than a lower score.
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
The prevalence and strength of markers of electrophysiological activity across the cerebellothalamocorticomuscular (CTCM) network at rest and during tremor-eliciting motor behaviors.
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
Examination of how the DN and VIM DBS (when present) modulate oscillatory activity and coupling across the CTCM circuit in relation to improvements in tremor control. A 4-8Hz (theta) tremor-related oscillation is observed consistently in the VIM during motor activity, which parallels the activity-dependent appearance of tremor in patients with ET.
Contact information is provided by the study sponsor or research team.
The Cleveland Clinic
Other
Acronym: rT DBS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04071847
Basal Ganglia Diseases, Brain Diseases
Tucson, Arizona, United States
View Trial DetailsNCT01734122
Basal Ganglia Diseases, Brain Diseases
Nashville, Tennessee, United States
View Trial DetailsNCT06378619
Basal Ganglia Diseases, Brain Diseases
Barcelona, Catalonia, Spain
View Trial DetailsNCT03884231
Basal Ganglia Diseases, Brain Diseases
Tucson, Arizona, United States
View Trial Details