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Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke

NCT06498934 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2024-07-18

No results posted yet for this study

Summary

The goal of this clinical trial is to learn if deep brain stimulation of the dentate nucleus (DN-DBS) works to promote chronic post-stroke upper limb motor function in adults. It will also learn about the safety of DN-DBS. The main questions it aims to answer are:

Does DN-DBS paired with rehabilitation improve the upper limb motor function of participants more than rehabilitation only? What medical problems do participants have when using DN-DBS for post-stroke rehabilitation?

Researchers will compare real DN-DBS+rehabilitation to sham DN-DBS+rehabilitation (electrodes will be implanted, but no electrical current is given) to see if DN-DBS works to promote chronic post-stroke upper limb motor function.

Participants will:

Undergo unilateral DN-DBS surgery Take real DN-DBS+rehabilitation or sham DN-DBS+rehabilitation as treatment for 6 months Visit the clinic every month during the DN-DBS+rehabilitation (treatment) period for programing, checkups and tests Visit the clinic at Day 1, 30, 90 and 365 after treatment period for checkups and tests

Conditions

  • Stroke
  • Upper Extremity Paresis

Interventions

DEVICE

deep brain stimulation

Stimulation of the dentate nucleus that is paired with upper limb rehabilitation movements.

OTHER

Rehabilitation

Rehabilitation movements to improve upper limb function after stroke

Sponsors & Collaborators

  • Beijing Pins Medical Co., Ltd

    collaborator INDUSTRY

  • Beijing Municipal Administration of Hospitals

    lead OTHER_GOV

Principal Investigators

  • Jianguo Zhang, MD · Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  • Zixiao Li, MD · Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT06498934 on ClinicalTrials.gov