Brain Network Changes in Essential Tremor with Deep Brain Stimulation

This study is looking at how the brain's networks change in people with essential tremor, especially those who have deep brain stimulation (DBS). Researchers will collect information about your brain activity using EEG (electroencephalography, which measures electrical activity) or MEG (magnetoencephalography, which measures magnetic fields). You might receive interventions like Alcohol, Alprazolam, Cold Therapy, or Peripheral Nerve Stimulation to see how they affect your tremor and brain activity. The goal is to understand how DBS works and how other treatments affect tremor. This study is for people aged 30 to 80 with essential tremor, whether or not they have DBS. Success for this study means understanding how brain networks change in response to these interventions and DBS. The current recruitment status is unclear.

Study design
This is an observational study planning to enroll 55 participants. It is not testing a new treatment but rather observing how existing interventions affect brain activity.
What's involved
You will have EEG or MEG recordings taken while resting and doing tasks. These recordings will be repeated with your DBS device on and off, and you may receive interventions like Alcohol, Alprazolam, Cold Therapy, or Peripheral Nerve Stimulation during an in-lab experiment lasting up to 8 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints are measured during an in-lab experiment lasting up to 8 hours. No further follow-up is specified.

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NCT06293638

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

Recruiting
Not specifiedAges 30–80Observational
The Cleveland Clinic
~55 participants
Updated 2026-05-08 on ClinicalTrials.gov
What's tested:AlcoholAlprazolamCold TherapyPeripheral Nerve Stimulation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
CTCM Coherence
Measured over up to 8 hours in-lab during experiment
+1 more outcome measured
Essential Tremor
1 sites across 1 states
Ohio1
  • James Liao, MD · PRINCIPAL_INVESTIGATOR · The Cleveland Clinic

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Eligibility criteria

Inclusion

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

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.
  • CTCM Coherenceup to 8 hours in-lab during experiment

    Coherence, a unitless measure of correlation between signals, calculated across the cerebellothalmocorticomuscular (CTCM) circuit, will be computed from neurophysiological recordings including electroencephalography (EEG), electromyography (EMG), magnetoencephalography (MEG), and/or local field potential (LFP), using data collected at rest, during tremor-eliciting tasks, with DBS OFF, with DBS ON (when available), and when using non-DBS tremor interventions (limb cooling and/or peripheral nerve stimulation and/or alprazolam or alcohol).

  • Power of oscillatory activity across the CTCM network in response to tremor interventionsup to 8 hours in-lab during experiment

    Power of tremor-related oscillatory activity, in the form of mean power in the 4-12Hz frequency band with units in mV\^2, will be computed from neurophysiological recordings including electroencephalography (EEG), electromyography (EMG), magnetoencephalography (MEG), and/or local field potential (LFP), using data collected at rest, during tremor-eliciting tasks, with DBS OFF, with DBS ON (when available), and when using non-DBS tremor interventions (limb cooling and/or peripheral nerve stimulation and/or alprazolam or alcohol).