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Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor

The Cleveland Clinic · NCT06293638

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 30–80 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
55
US sites recruiting
1
Study start
March 25, 2024
Record last updated
May 8, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Alcohol; Alprazolam; Cold Therapy; Peripheral Nerve Stimulation

Conditions: Essential Tremor

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Jeff Negrey, MA · 216-636-5504 · negreyj2@ccf.org

Study contacts (from the official record)

  • Jeffrey Negrey, MA · 2163166896 · negreyj2@ccf.org
  • Madeline Porter · 2167691866 · porterm11@ccf.org
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Functional Brain Network Changes in Patients Undergoing Deep Brain… (NCT06293638) | Bored Studies