Spinal Cord Stimulation for Parkinsonism: a Single-center, Single-arm Open Trial

Status: Recruiting

Location: See location...

Intervention Type: Device

Study Type: Interventional

Study Phase: Not Applicable

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.

Eligibility

Participation Requirements

Sex: All

Minimum Age: 50

Maximum Age: 80

Healthy Volunteers: f

View:

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

• Aged between 50 and 80 years

• Able and willing to follow instruction of the researcher

• No other conditions that the researchers consider inappropriate for inclusion

Locations

Other Locations

China

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

RECRUITING

Shanghai

Contact Information

Primary

Jun Liu, MD,PhD

jly0520@hotmail.com

021-64370045

Time Frame

Start Date: 2021-05-01

Estimated Completion Date: 2026-12-31

Participants

Target number of participants: 50

Treatments

Experimental: 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.

Related Therapeutic Areas

Chronic Pain

Movement Disorders

Low Blood Pressure

Familial Dysautonomia

Parkinson's Disease

Dysarthria

Orthostatic Hypotension