Smart brain device zaps tremors only when needed
NCT ID NCT02649166
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new type of deep brain stimulation for essential tremor that only delivers electricity when a tremor is detected, rather than constantly. The goal is to reduce side effects like slurred speech and walking problems, and make the battery last longer. About 20 adults with severe, medication-resistant hand tremors will be enrolled to see if this 'closed-loop' approach is safe and effective.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2017
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. You provide informed consent. 2. You are over 21 years of age. 3. You are diagnosed with a postural-intention (essential) tremor for at least 3 years and meet strict diagnostic criteria and have been seen and examined by a movement disorders fellowship trained neurologist. 4. You have had a significant disabling medical-refractory upper extremity tremor with no evidence of supraspinal central nervous system disease or injury (tremor not adequately controlled by medications for at least three (3) months before implant). 5. You have had a postural or kinetic tremor severity score of at least 2 out of 4 in the extremity intended for treatment on the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor (CRST). 6. You have had a CRST score of 2 or above in any one of the items 16-23 from the Disability subsection of the CRST: speaking, feeding other than liquids, bringing liquids to mouth, hygiene, dressing, writing, working and social activities. 7. Your tremor is refractory adequate trials of at least two medications, one of which should be either propranolol or primidone. An adequate medication trial is defined as a therapeutic dose of each medication or the development of side effects as the medication dose is titrated. 8. You are available for appropriate follow-up times for the length of the study. Exclusion Criteria: 1. Any previous neurosurgical intervention including deep brain stimulation or ablative brain lesions. 2. Medication related movement disorders. 3. Any suspicion of Parkinsonian tremor, including presence of Parkinsonian features such as bradykinesia, rigidity, or postural instability. 4. Any behaviors consistent with ethanol or substance abuse as defined by the criteria outlined in DSM-V. 5. Severe medical co-morbidity including cardiovascular disorder, lung disorder, kidney disease, continuous neurological disease, hematological disease, or frailty that impact tolerability of the surgery as judged by the screening physicians. 6. Abnormal brain MRI including hydrocephalus, stroke, structural lesions, demyelinating lesions, or infectious lesions. Also excluded will be subjects with severe atrophy. 7. Any uncontrolled symptoms or signs of increased intracranial pressure (e.g., headache, nausea, vomiting, lethargy, papilledema). 8. A history of seizures within the past year. 9. A dementia rating scale score (DRS) \<130 signifying significant cognitive dysfunction and a potential for inability to cooperate with tasks involved in the study. 10. Any attempt or intent of suicide in the last six months. 11. Presence or history of psychosis. 12. Significant or active mood disorders including depression. For the purpose of this study, we consider a significant mood disorder to include any subject who has: 1. Scores ≥ 20 on the Patient Health Questionnaire - 9 (PHQ-9). 2. Currently under the care of a psychiatrist 3. Currently participating in cognitive-behavioral therapy 4. Been hospitalized for the treatment of a psychiatric illness within 12 months 5. Ever received transcranial magnetic stimulation 6. Ever received electroconvulsive therapy n. In addition, patients who are pregnant or plan to become pregnant will be excluded from this study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Florida
Gainesville, Florida, 32611, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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