Examining brain changes in patients with essential tremor receiving deep brain stimulation
Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor
This study is testing how deep brain stimulation affects brain activity in people with essential tremor to find better ways to manage their symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 55 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | The Cleveland Clinic Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06293638 on ClinicalTrials.gov |
What this trial studies
This study aims to collect electrophysiological data to understand how deep brain stimulation (DBS) affects brain networks in patients with essential tremor. Participants will undergo either electroencephalography (EEG) or magnetoencephalography (MEG) to record brain activity during different states of DBS, including optimal and sub-optimal settings. The study will also explore the effects of non-DBS tremor mitigation techniques, such as medication and cooling therapies. By analyzing these data, researchers hope to identify new therapeutic targets to improve tremor control.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 30 to 80 with a clinical diagnosis of essential tremor and a disease duration of at least 3 years.
Not a fit: Patients with significant psychiatric symptoms or cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with essential tremor.
How similar studies have performed: Other studies have shown promise in understanding brain network changes with DBS, making this approach both relevant and potentially impactful.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Between 30 and 80 years of age; * Ability to provide informed consent; * Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and being treated with a DBS; OR * Clinical diagnosis of ET by a movement disorders neurologist with a disease duration of at least 3 years and not being treated with a DBS; OR * No known neurological disease or disorder. Exclusion Criteria: * The individual has a condition that, in the opinion of the investigator, would significantly increase the risk for interference with study compliance, safety, or outcome; * Presence of active psychiatric symptoms meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for Axis-I disorder on formal psychiatric evaluation other than depression or anxiety; * History of cognitive impairment meeting Diagnostic and Statistical Manual of Mental Disorders-4th Edition (DSM-IV) criteria for dementia on formal neuropsychological evaluation, as documented in chart; * Lack of English-language fluency which would interfere with the ability to understand the study consenting process and potential study risks; * Hearing or visual impairment precluding testing; * Motor impairment impacting test responses (i.e., orthopedic injury or disease); * Anyone currently taking medications with Antabuse-like effects (e.g. Flagyl, Bactrim, Tindamax) will be excluded from any alcohol administration.
Where this trial is running
Cleveland, Ohio
- Cleveland Clinic — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: James Liao, MD — The Cleveland Clinic
- Study coordinator: Jeffrey Negrey, MA
- Email: negreyj2@ccf.org
- Phone: 2163166896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.