Spinal Cord Stimulation for Parkinsonism (SCS for PDS)

Shanghai Jiao Tong University

Status: Enrolling

Conditions: Parkinsonism

Treatments: Device: Spinal cord stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05171205

SCS_PDS

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

50 participants in 1 patient group

Spinal cord stimulation(SCS) implantation

Experimental group

Description:

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.

Treatment:

Device: Spinal cord stimulation