NCT06293638 Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor
| NCT ID | NCT06293638 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The Cleveland Clinic |
| Condition | Essential Tremor |
| Study Type | OBSERVATIONAL |
| Enrollment | 55 participants |
| Start Date | 2024-03-25 |
| Primary Completion | 2028-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 55 participants in total. It began in 2024-03-25 with a primary completion date of 2028-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to collect electrophysiological data related to functional brain network changes in patients undergoing deep brain stimulation for the treatment of essential tremor. Participants will either 1) have electroencephalography (EEG) scalp electrodes placed, or 2) remain seated with their head inside of a magnetoencephalography (MEG) recording system, as resting-state and task-related data are acquired. Spontaneous electrophysiological activity will be recorded in both the eyes open and eyes closed conditions with the participant seated comfortably. These recordings will be repeated in the DBS OFF and DBS ON states, with the ON state involving specific settings identified as optimal, sub-optimal, or ineffective at achieving tremor control. They will also be repeated following the optional administration non-DBS tremor mitigation techniques, which may include one or more of the following: 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation.
Eligibility 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.
Contact & Investigator
James Liao, MD
PRINCIPAL INVESTIGATOR
The Cleveland Clinic
Frequently Asked Questions
Who can join the NCT06293638 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, up to 80 Years, studying Essential Tremor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06293638 currently recruiting?
Yes, NCT06293638 is actively recruiting participants. Contact the research team at negreyj2@ccf.org for enrollment information.
Where is the NCT06293638 trial being conducted?
This trial is being conducted at Cleveland, United States.
Who is sponsoring the NCT06293638 clinical trial?
NCT06293638 is sponsored by The Cleveland Clinic. The principal investigator is James Liao, MD at The Cleveland Clinic. The trial plans to enroll 55 participants.