Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age21+
SponsorThe Cleveland Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Deep Brain Stimulation
DeviceDeep Brain Stimulation of the Deep Cerebellar Nuclei
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: Refractory TremorExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The incidence and nature of treatment-related adverse events
The accumulation of adverse events across all subjects
Time frame
From DBS Implant Surgery through study completion, an average of 17 monthsSecondary outcomes
1
Fahn Tolosa Marin Tremor Rating Scale
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 months2
DBS-evoked potentials
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 months3
4-8 HZ (theta) tremor related oscillations
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.
Time frame
From DBS Implant Surgery through study completion, an average of 17 monthsSponsors and contacts
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Source ClinicalTrials.gov