TremorPhase 1rT DBSNCT07049003
Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
A Phase 1 study testing Deep Brain Stimulation in people with Tremor and Essential Tremor, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Tremor, Essential Tremor
- What is being tested?
- Deep Brain Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2026to 31 Dec 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 15Show fewer
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Jeffrey Negrey, MA, 2163166896, negreyj2@ccf.org
About this study
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.
- Conditions
- Tremor, Essential Tremor
- Being tested
- Deep Brain Stimulation
- Medical subject headings
- Tremor, Essential Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Deep Brain StimulationDevice
Also called Medtronic Percept DBS System
Deep Brain Stimulation of the Deep Cerebellar Nuclei
| Study group | Role | What they receive |
|---|---|---|
| Refractory Tremor | Experimental | Medtronic Percept RC DBS System Receives: Device: Deep Brain Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and nature of treatment-related adverse events
The accumulation of adverse events across all subjects
Measured: From DBS Implant Surgery through study completion, an average of 17 months
Secondary outcomes (3)
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.
Measured: From DBS Implant Surgery through study completion, an average of 17 months
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.
Measured: From DBS Implant Surgery through study completion, an average of 17 months
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.
Measured: From DBS Implant Surgery through study completion, an average of 17 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2025
- Study start15 Jan 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TremorStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive open label deep brain stimulation implantation of the deep cerebellar nuclei
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Raynor Cerebellum Project, Medtronic
- Responsible party
- Principal investigator, Andre Machado, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07049003
- Sponsor's protocol ID
- 25-182
- Acronym
- rT DBS
- Status last verified
- Jul 2026
- First submitted
- 28 May 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Brain Stimulation of the Deep Cerebellar Nuclei for Refractory Tremor
- ClinicalTrials.gov ID
- NCT07049003
- Acronym / sponsor ID
- rT DBS / 25-182
- Conditions
- Tremor, Essential Tremor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- Raynor Cerebellum Project, Medtronic
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 3 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive open label deep brain stimulation implantation of the deep cerebellar nuclei
| Arm | Type | Receives |
|---|---|---|
| Refractory Tremor | Experimental | Device: Deep Brain StimulationMedtronic Percept RC DBS System |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (15 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Deep Brain StimulationAlso: Medtronic Percept DBS SystemDeep Brain Stimulation of the Deep Cerebellar Nuclei | Device | Refractory Tremor |
Primary outcome
The incidence and nature of treatment-related adverse events
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
The accumulation of adverse events across all subjects
3 secondary outcomes
Fahn Tolosa Marin Tremor Rating Scale
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
DBS-evoked potentials
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
4-8 HZ (theta) tremor related oscillations
Time frame: From DBS Implant Surgery through study completion, an average of 17 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Tremor
RecruitingObservational study
The Encora X1™ in a Real World Observational Study
Essential Tremor
Recruiting
False Vocal Fold vs EMG Guided Botox for Vocal Tremor
Vocal Tremor
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Not yet recruitingPhase 3
Effect of Botulinum Toxin on Resting Tremor of the Refractory Upper Limb in Parkinsonians
PARKINSON DISEASE (Disorder)
RecruitingObservational study
Analysis of Cutaneous Phosphorylated Alpha-Synuclein to Identify Patients at Risk of Progressing From Essential Tremor to Parkinson's Disease
Essential Tremor, Movement Disorders, Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Deep Brain Stimulation in people with Tremor and Essential Tremor, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeffrey Negrey, MA (2163166896, negreyj2@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and nature of treatment-related adverse events (time frame: From DBS Implant Surgery through study completion, an average of 17 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.