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Interleaving Stimulation Improves Dyskinesia in Parkinson's Disease

NCT06239454 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-02

No results posted yet for this study

Summary

This study is designed as a prospective, randomized, double-blind, controlled study to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to post-operation dyskinesia control. The primary objective is to assess putative differences in the effect of interleaving stimulation and empirical stimulation with regards to dyskinesia control.

Conditions

Interventions

DEVICE

interleaving stimulation

ILS consists of two rapid and alternate stimulation programs with different contacts, amplitudes, and pulse width but the same frequency up to a maximum of 125Hz. Contact selection is determined by postoperative stereotactic computed tomography and clinical evaluation to achieve a balance between motor improvement and tolerable side effects. For example, ILS is successfully applied for PD motor symptoms (stimulation of subthalamic nucleus) as well as dyskinesia (additional stimulation of zona incerta).

DEVICE

empirical stimulation

Patients are settled with simple polar stimulation with combined parameters adjustment (monopolar mode, 60\~90µs pulse width, 130\~185Hz frequency and varied voltage) during the follow-up.

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Feng-Tao Liu, MD · Huashan Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2024-12-01
Completion
2025-02-28

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06239454 on ClinicalTrials.gov