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

Conditions

• Essential Tremor

Eligibility Criteria

Sex

ALL

Age

30 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• Alcohol — DRUG
  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 — DRUG
  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 — DEVICE
  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 — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Mar 25, 2024

Status verified

Apr 2026

Primary completion

Dec 31, 2028

Completion

Dec 31, 2028

Study Design

Enrollment

55 participants (estimated)

Arms

• Arm: 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
• Arm: 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
• Arm: No Known Neurological Disease or Disorder
  1. 30-80 years of age 2. No known neurological disease or disorder

Primary Outcome Measure

CTCM Coherence [ Time Frame: up to 8 hours in-lab during experiment ]

Central Contacts

• Jeffrey Negrey, MA
  2163166896
  [email protected]
• Madeline Porter
  2167691866
  [email protected]

Locations (1)

Find similar trials in Cleveland, OH

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