Directional Bilateral Thalamic Patterned Stimulation (Chronos)

Status Not yet recruiting

Clinical Trial Summary

Population Size and Eligible Patients: The investigators aim to recruit 5 to 10 patients with tremors who have previously undergone Ventral Intermedius Deep Brain Stimulation (VIM-DBS) treatment but have experienced early or late loss of benefits. Additionally, the investigators will enroll ten patients with essential tremor who require VIM-DBS surgery. These individuals will undergo bilateral implantation of Boston Scientific Genus Implantable Pulse Generator (IPG) devices, connected to Boston Scientific Cartesia™ 8-contact Directional Leads. Study Design: This study comprises two distinct phases. Phase 1 is a cross-sectional investigation designed to identify the optimal algorithm for patterned stimulation in the VIM region . Phase 2 is a prospective clinical trial focusing on the assessment of safety and efficacy of bilateral VIM-DBS in patients with essential tremor. Objectives: The primary objective in Phase 2 is to evaluate the safety and effectiveness of bilateral VIM-DBS in individuals with essential tremor. In Phase 1, the investigators seek to explore the impact of the Chronos programming software on tremor patients who have experienced early or late loss of benefits.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06325852
Study type	Interventional
Source	University of Toronto
Contact
Status	Not yet recruiting
Phase	N/A
Start date	August 1, 2024
Completion date	January 1, 2027

View Details

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Withdrawn	`NCT05381688` - VIM DBS Respiratory Modulation: N-of-1 Trial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