← Back to Search

Essential Tremor with DBS for Essential Tremor (TRaNCE Trial)

N/A
Recruiting
Led By James Liao, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 hours in-lab during experiment
Awards & highlights

TRaNCE Trial 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 be asked to 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 1) cooling the limb, 2) oral administration of alprazolam, 3) oral consumption of ethanol (alcohol), or 4) peripheral nerve stimulation.

Eligible Conditions
  • Essential Tremor

TRaNCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 hours in-lab during experiment
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 hours in-lab during experiment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
CTCM Coherence
Power of oscillatory activity across the CTCM network in response to tremor interventions
Secondary outcome measures
Essential tremor severity: Grip force
Essential tremor severity: Limb acceleration
Essential tremor severity: Tremor Research Group Essential Tremor Rating Scale (TETRAS)

TRaNCE Trial Design

3Treatment groups
Experimental Treatment
Group I: No Known Neurological Disease or DisorderExperimental Treatment4 Interventions
40-80 years of age No known neurological disease or disorder
Group II: Essential Tremor without DBSExperimental Treatment4 Interventions
40-80 years of age Diagnosis of ET Has not been previously implanted with a DBS system for disease management per standard of care
Group III: Essential Tremor with DBSExperimental Treatment4 Interventions
40-80 years of age Diagnosis of ET Previously implanted with a DBS system for disease management per standard of care
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Alcohol
2008
Completed Phase 3
~2000
Peripheral Nerve Stimulation
2016
Completed Phase 1
~1380
Cold Therapy
2017
N/A
~40
Alprazolam
2009
Completed Phase 4
~1570

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,366,031 Total Patients Enrolled
2 Trials studying Essential Tremor
87 Patients Enrolled for Essential Tremor
James Liao, MDPrincipal InvestigatorThe Cleveland Clinic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor
James Liao 2024. "Functional Brain Network Changes in Patients Undergoing Deep Brain Stimulation for Essential Tremor". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06293638.
All > Cleveland
~30 spots leftby Dec 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top