NCT06121947

Safety and Efficacy Study of Implantable Neuromodulation for Poststroke Hemiplegia

Not yet recruiting NA Last updated 8 November 2023

What this trial tests

NA trial testing The DBS electrodes are implanted into MLR. in Stroke Sequelae in 98 participants. Not yet recruiting.

Timeline

10 November 2023

Primary endpoint
30 October 2029

30 October 2030

Quick facts

Lead sponsor	Chinese PLA General Hospital
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	98
Start date	10 November 2023
Primary completion	30 October 2029
Estimated completion	30 October 2030
Sites	1 location across China

Drugs / interventions tested

• The DBS electrodes are implanted into MLR.
• The electrodes are implanted into the patient's vagus nerve

Conditions studied

• Stroke Sequelae — all drugs for Stroke Sequelae →
• Deep Brain Stimulation — all drugs for Deep Brain Stimulation →
• Vagus Nerve Stimulation — all drugs for Vagus Nerve Stimulation →
• Motor Recovery — all drugs for Motor Recovery →

Sponsor

Chinese PLA General Hospital

Who can join

Adults 18 to 80, any sex, with Stroke Sequelae or Deep Brain Stimulation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Hemiplegia is a common complication after a stroke. Studies have shown that traditional medical and rehabilitation treatments are not good for improving patients' motor function, deep brain stimulation (DBS) and vagus nerve stimulation (VNS) can improve the motor function of patients, but there is no comparative study between them. Objectives: This study compares the efficacy and safety of DBS and VNS in the recovery of motor function in patients with post-stroke hemiplegia, determining the best treatment for patients with post-stroke hemiplegia, and providing high-level clinical evidence for patients and clinicians to choose from. Methods/Design: This is a randomized, double-blind, sham-controlled, cross-controlled pilot study. A total of 98 patients with post-stroke hemiplegia are assigned to receive DBS or VNS. After 3 and 6 months of follow-up, all the devices are turned off. After a 2-week washout, the control group is turned on, but the stimulation group is given sham stimulation. After 9 and 12 months of follow-up, all the devices are turned on. Then, at postoperative 15 and 18 months, postoperative neuroimaging and various post-stroke motor-related scores were performed for data collection and analysis. Discussion: We propose a study design and rationale to compare the efficacy and safety of DBS and VNS in patients with post-stroke hemiplegia to provide evidence and reference for implantable neuromodulation in the treatment of post-stroke dysfunction, and to compare the therapeutic effects of DBS and VNS to provide evidence for patient and clinical diagnosis and treatment choices. Study limitations are related to the small sample size and short study period.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Deep brain stimulation versus vagus nerve stimulation for the motor function of poststroke hemiplegia: study protocol for a multicentre randomised controlled trial.
   Xu J, Liu B, Shang G, Liu S, et al · · 2024 · PMID 39384245 · DOI 10.1136/bmjopen-2024-086098