Spinal Cord Stimulation for Parkinsonism

NCT ID: NCT05171205

Last Updated: 2025-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2026-12-31

Brief Summary

Spinal Cord Stimulation (SCS) is a newly emerged neuromodulation technique in recent years. It is now a mature technique in the treatment of chronic pain and is generally accepted by patients because of its non-destructive and reversible nature, few complications, no side effects, and avoidance of unnecessary surgical procedures. Combining the results of previous studies and the group's previous research, this study first proposes an innovative treatment protocol for PDS with SCS. We intend to conduct a prospective single-center open clinical trial to evaluate the improvement of orthostatic hypotension, urinary retention, sleep disturbance, dysarthria, and dysphagia in Parkinsonism (PDS) patients before and after SCS treatment, and shed new light on the treatment for PDS.

Conditions

Parkinsonism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spinal cord stimulation(SCS) implantation

Phase I:

1. Spinal cord segment is selected as the puncture location according to the patient's symptom and the condition of the patient's spinal cord. Percutaneous puncture is performed under X-ray guidance. One or two electrodes are placed in the patient's epidural cavity, and the electrode position is adjusted intraoperatively and by the patient's feedback of the current stimulation position until the current can cover the entire area.

2. An extension lead is connected, an external temporary stimulator is attached, and the patient decides whether to proceed to full implantation in phase II after 7-10 days of phase I testing experience.

Phase II:

The complete SCS system is implanted under local anesthesia or epidural anesthesia after successful testing. A subcutaneous capsular bag is usually created in the lower abdomen and the implanted electrodes are connected to the pulse generator through a connecting wire in the subcutaneous tunnel.

Group Type: EXPERIMENTAL

Spinal cord stimulation

Intervention Type: DEVICE

Spinal cord stimulation (SCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibers to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.

Interventions

Spinal cord stimulation

Spinal cord stimulation (SCS) is a very thin electrode implanted in the dorsal epidural space of the spinal cord to improve the patient's symptoms by stimulating the spinal nerves with pulsed electrical currents, which attenuate or enhance the flow of nerve impulses from the periphery to the central system, i.e., stimulating thick fibers to achieve therapeutic results. SCS system consists of three components: an electrode implanted in the epidural space of the patient's spinal cord, a stimulator implanted subcutaneously in the abdomen or buttocks that delivers electrical impulses, and an extension cord that connects the two.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Diagnosed with parkinsonism according to MDS clinical diagnostic criteria for Parkinson's disease

2. Aged between 50 and 80 years

3. Able and willing to follow instruction of the researcher

4. No other conditions that the researchers consider inappropriate for inclusion

Exclusion Criteria

1. Severe depression (HAMD-17 above 17 as moderate to severe) or anxiety

2. Pregnancy

3. History of alcoholism

4. Non-neurological disease-related symptoms that prevent patients from participation in the study

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Liu, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Ruijin Hospital

Locations

Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Jun Liu, MD,PhD

Role: CONTACT

jly0520@hotmail.com

021-64370045

Facility Contacts

Jun Liu, MD,PhD

Role: primary

jly0520@hotmail.com

64370045 ext. +86-021

Other Identifiers

SCS_PDS

Identifier Type: -

Identifier Source: org_study_id