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

Status: Recruiting
Location: See location...
Intervention Type: Drug, Device, Procedure
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
United States
Ohio
Cleveland Clinic
RECRUITING
Cleveland
Contact Information
Primary
Jeffrey Negrey, MA
negreyj2@ccf.org
2163166896
Backup
Madeline Porter
porterm11@ccf.org
2167691866
Time Frame
Start Date: 2024-03-25
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 55
Treatments
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
Sponsors
Leads: The Cleveland Clinic

This content was sourced from clinicaltrials.gov