Recruiting

Deep Brain Stimulation

Sponsor:

The Cleveland Clinic

Code:

NCT06293638

Conditions

Essential Tremor

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

Interventions

Alcohol

Alprazolam

Cold Therapy

Peripheral Nerve Stimulation

Study Details

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.

Conditions

Essential Tremor

Study ID

NCT06293638

Start date

Mar 25, 2024

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

55 participants

Anticipated

Interventions and Outcome Measures

Arms

Essential Tremor with DBS

1. 30-80 years of age
2. Diagnosis of ET
3. Previously implanted with a DBS system for disease management per standard of care

Essential Tremor without DBS

1. 30-80 years of age
2. Diagnosis of ET
3. Has not been previously implanted with a DBS system for disease management per standard of care

No Known Neurological Disease or Disorder

1. 30-80 years of age
2. No known neurological disease or disorder

Interventions

Alcohol

Alcohol consumption is shown to reduce tremor in individuals with essential tremor. The alcoholic beverage will be dispensed by the a clinician study investigator, and the participant will be administered the alcoholic beverage until their tremor is decreased, as determined by the clinician. Individual sensitivity to the tremor-mitigating effects of alcohol varies, but it is anticipated that only light (1-2 40% ABV drinks, containing 1-2 units of absolute alcohol \[10 mL. or 8 g of pure ethanol\]) consumption will be necessary. Participants will then repeat motor task and data collection while the alcohol is effective at controlling tremor, beginning approximately 15-20 minutes after consumption.

Alprazolam

Alprazolam is shown to reduce tremor in individuals with essential tremor. The primary investigator will select the appropriate dose for the patient (0.5mg for patients with a body weight of up to 75kg, and 0.75mg for participants with a body weight of 75kg and higher). Participants will swallow the drug with a glass of water in the presence of the research team. If participants have not reached a sufficient level of tremor improvement, a subsequent dose of up to a total of 1.0mg of alprazolam per participant will be requested. Participants will then repeat motor task and data collection.

Cold Therapy

One or both of the participant's upper limbs will be wrapped with pre-chilled ice packs or a cold water circulating device such as a cryomanchet (e.g., the Breg PolarCare Glacier), and the skin temperature monitored until it lowers to 15-25°C. Participants will then repeat motor task and data collection while the limb is cool.

Peripheral Nerve Stimulation

Electrical stimulation will be applied using techniques similar to those applied during standard somatosensory evoked potential testing. Specifically, adhesive surface electrodes will be placed above the median and radial nerves at the wrist. Stimulation paradigms will be tailored to each participant based on the frequency characteristics of their tremor. Participants will receive between 20-60 minutes of stimulation, then will repeat motor task and data collection. Transcutaneous peripheral nerve stimulation may help mitigate tremor, with effects lasting beyond cessation of stimulation1-3.

Primary outcome measure

  • CTCM Coherence [ Time Frame: up to 8 hours in-lab during experiment ]
  • Power of oscillatory activity across the CTCM network in response to tremor interventions [ Time Frame: up to 8 hours in-lab during experiment ]

Central Contacts and Locations

Central contacts

Jeffrey Negrey, MA

2163166896negreyj2@ccf.org

Madeline Porter

2167691866porterm11@ccf.org

Locations

Cleveland Clinic

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Jeff Negrey, MA

216-636-5504negreyj2@ccf.org

Principal Investigator:

James Liao, MD

More Information

Sponsor

The Cleveland Clinic

Last update posted

May 8, 2026

Last verified

Apr, 2026

Keywords

  • essential tremor
  • deep brain stimulation
  • DBS
  • ET
  • tremor
  • hand tremors

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-05-08.