Clinical Trials Logo

Clinical 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.


Clinical Trial Description

Electrophysiological data from participants will be collected during Magnetoencephalography (MEG) procedures. The MEG experiments, will utilize recordings from the DBS system that may be synchronized to externally recorded signals (e.g., MEG, EEG, EMG, accelerometry) via gentle tap-induced motion artifacts, and/or by applying a small, barely perceptible electrical current at the skin over the DBS system with use of a Transcutaneous Electrical Nerve Stimulation (TENS) unit. It is hypothesized that the chronic, electrical stimulation of the target region has both local and circuit-wide effects, the net effect of which is to disrupt the pathophysiological neural activity present across both cortical and subcortical brain regions that and thought to underlie disease manifestation (i.e., tremor). By systemically characterizing the pathways involved in propagating tremor-related activity as well as mediating treatment-related benefits, the investigators hope to identify potential new therapeutic targets or treatment paradigms to further optimize tremor control in this population. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06293638
Study type Observational
Source The Cleveland Clinic
Contact Jeffrey Negrey, MA
Phone 2163166896
Email negreyj2@ccf.org
Status Recruiting
Phase
Start date March 25, 2024
Completion date December 31, 2026

See also
  Status Clinical Trial Phase
Withdrawn NCT05381688 - VIM DBS Respiratory Modulation: N-of-1 Trial
Recruiting NCT05101161 - Neurofeedback Using Implanted Deep Brain Stimulation Electrodes N/A
Completed NCT02277106 - Evaluate SAGE-547 in Participants With Essential Tremor Phase 2
Recruiting NCT05769933 - Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
Terminated NCT02678429 - Atlas Predicted DBS Settings in Essential Tremor N/A
Terminated NCT02894567 - Evaluation of Directional Recording and Stimulation Using spiderSTN N/A
Completed NCT02523807 - Tremor Monitoring Device N/A
Active, not recruiting NCT02255929 - Gamma Knife Radiosurgery for Treatment of Essential Tremor N/A
Completed NCT01223144 - Decision-making and Emotion Recognition in Essential Tremor N/A
Completed NCT00906412 - Ventrointermediate Nucleus (VIM DBS) and Working Memory N/A
Recruiting NCT05214222 - Penpulimab Plus Chemotherapy With/Without Anlotinib for Patients With Advanced Esophageal Squamous Cell Carcinoma Phase 2
Completed NCT03051178 - Wearable Sensor for Responsive DBS for ET N/A
Recruiting NCT03795935 - Relief From Side Effects: Clinical Use of Electrodes With Direction N/A
Not yet recruiting NCT06036368 - Study to Evaluate Safety and Efficacy of Peroneal Transcutaneous NeuroModulation in Subjects With Parkinson's Disease and Essential Tremor N/A
Recruiting NCT05897775 - Coordinated Reset Deep Brain Stimulation for Essential Tremor Phase 1
Recruiting NCT05968976 - Multicentre RCT of Awake Versus Asleep Tractography Based DBS for ET N/A
Completed NCT06314139 - Tolerability and Efficacy of Continuous Theta-burst Stimulation for Essential Tremor: A Randomized Study. N/A
Recruiting NCT04501133 - Sensory-specific Peripheral Stimulation for Tremor Management N/A
Active, not recruiting NCT03560622 - Functional Neuroimaging Feedback for Focused Ultrasound Thalamotomy N/A
Completed NCT00368199 - Transcranial Duplex Scanning and Single Photon Emission Computer Tomography (SPECT) in Parkinsonian Syndromes N/A