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

Ruijin Hospital1 site in 1 country50 target enrollmentMay 1, 2021

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: Ruijin Hospital
Enrollment: 50
Locations: 1
Primary Endpoint: Change of blood pressure from baseline to 3 months post-operation
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2021

End Date

December 31, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Ruijin Hospital

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Change of blood pressure from baseline to 3 months post-operation

Time Frame: 3 months

Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 3 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Change of blood pressure from baseline to 6 months post-operation

Time Frame: 6 months

Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 6 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Change of blood pressure from baseline to 9 months post-operation

Time Frame: 9 months

Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 9 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Change of blood pressure from baseline to 12 months post-operation

Time Frame: 12 months

Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 12 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Change of blood pressure from baseline to 18 months post-operation

Time Frame: 18 months

Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 18 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Change of blood pressure from baseline to 24 months post-operation

Time Frame: 24 months

Change of on-off delta systolic blood pressure and delta diastolic blood pressure from baseline to 24 months post-operation. Delta systolic blood pressure equals the systolic blood pressure of the patient lying minus the systolic blood pressure of the patient standing up for 10 minutes. Delta diastolic blood pressure equals the diastolic blood pressure of the patient lying minus the diastolic blood pressure of the patient standing up for 10 minutes.

Secondary Outcomes

Change of TUG from baseline to 6 months post-operation(6 months)
Change of TUG from baseline to 9 months post-operation(9 months)
Change of TUG from baseline to 12 months post-operation(12 months)
Change of TUG from baseline to 18 months post-operation(18 months)
Change of TUG from baseline to 24 months post-operation(24 months)
Change of apnea hypopnea index from baseline to 3 months post-operation(3 months)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation(9 months)
Change of oxygen desaturation index from baseline to 3 months post-operation(3 months)
Change of oxygen desaturation index from baseline to 6 months post-operation(6 months)
Change of oxygen desaturation index from baseline to 9 months post-operation(9 months)
Change of oxygen desaturation index from baseline to 12 months post-operation(12 months)
Change of oxygen desaturation index from baseline to 18 months post-operation(18 months)
Change of oxygen desaturation index from baseline to 24 months post-operation(24 months)
Change of apnea hypopnea index from baseline to 6 months post-operation(6 months)
Change of apnea hypopnea index from baseline to 9 months post-operation(9 months)
Change of urinary retention from baseline to 12 months post-operation(12 months)
Change of apnea hypopnea index from baseline to 12 months post-operation(12 months)
Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation(9 months)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation(3 months)
Change of apnea hypopnea index from baseline to 18 months post-operation(18 months)
Change of apnea hypopnea index from baseline to 24 months post-operation(24 months)
Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation(3 months)
Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation(6 months)
Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation(12 months)
Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation(18 months)
Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation(24 months)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation(6 months)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation(9 months)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation(12 months)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation(18 months)
Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation(24 months)
Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation(3 months)
Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation(6 months)
Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation(9 months)
Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation(12 months)
Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation(18 months)
Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation(24 months)
Change of on-off delta heart rate variability from baseline to 3 months post-operation(3 months)
Change of on-off delta heart rate variability from baseline to 6 months post-operation(6 months)
Change of on-off delta heart rate variability from baseline to 9 months post-operation(9 months)
Change of on-off delta heart rate variability from baseline to 12 months post-operation(12 months)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation(6 months)
Change of on-off delta heart rate variability from baseline to 18 months post-operation(18 months)
Change of on-off delta heart rate variability from baseline to 24 months post-operation(24 months)
Change of length of walking during 6-minute walking test from baseline to 3 months post-operation(3 months)
Change of length of walking during 6-minute walking test from baseline to 6 months post-operation(6 months)
Change of length of walking during 6-minute walking test from baseline to 9 months post-operation(9 months)
Change of length of walking during 6-minute walking test from baseline to 12 months post-operation(12 months)
Change of length of walking during 6-minute walking test from baseline to 18 months post-operation(18 months)
Change of length of walking during 6-minute walking test from baseline to 24 months post-operation(24 months)
Change of time of walking during 6-minute walking test from baseline to 3 months post-operation(3 months)
Change of time of walking during 6-minute walking test from baseline to 6 months post-operation(6 months)
Change of time of walking during 6-minute walking test from baseline to 9 months post-operation(9 months)
Change of time of walking during 6-minute walking test from baseline to 12 months post-operation(12 months)
Change of time of walking during 6-minute walking test from baseline to 18 months post-operation(18 months)
Change of time of walking during 6-minute walking test from baseline to 24 months post-operation(24 months)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation(3 months)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation(6 months)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation(9 months)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation(12 months)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation(18 months)
Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation(24 months)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation(3 months)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation(12 months)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation(18 months)
Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation(24 months)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation(3 months)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation(6 months)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation(9 months)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation(12 months)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation(18 months)
Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation(24 months)
Change of dysarthria symptom from baseline to 3 months post-operation(3 months)
Change of dysarthria symptom from baseline to 6 months post-operation(6 months)
Change of dysarthria symptom from baseline to 9 months post-operation(9 months)
Change of dysarthria symptom from baseline to 12 months post-operation(12 months)
Change of dysarthria symptom from baseline to 18 months post-operation(18 months)
Change of dysarthria symptom from baseline to 24 months post-operation(24 months)
Change of urinary retention from baseline to 3 months post-operation(3 months)
Change of urinary retention from baseline to 6 months post-operation(6 months)
Change of urinary retention from baseline to 9 months post-operation(9 months)
Change of urinary retention from baseline to 18 months post-operation(18 months)
Change of urinary retention from baseline to 24 months post-operation(24 months)
Change of MDS-UPDRS from baseline to 3 months post-operation(3 months)
Change of MDS-UPDRS from baseline to 6 months post-operation(6 months)
Change of MDS-UPDRS from baseline to 9 months post-operation(9 months)
Change of MDS-UPDRS from baseline to 12 months post-operation(12 months)
Change of MDS-UPDRS from baseline to 18 months post-operation(18 months)
Change of MDS-UPDRS from baseline to 24 months post-operation(24 months)
Change of UMSARS from baseline to 3 months post-operation(3 months)
Change of UMSARS from baseline to 6 months post-operation(6 months)
Change of UMSARS from baseline to 9 months post-operation(9 months)
Change of UMSARS from baseline to 12 months post-operation(12 months)
Change of UMSARS from baseline to 18 months post-operation(18 months)
Change of UMSARS from baseline to 24 months post-operation(24 months)
Change of lowest oxygen saturation from baseline to 3 months post-operation(3 months)
Change of lowest oxygen saturation from baseline to 6 months post-operation(6 months)
Change of lowest oxygen saturation from baseline to 9 months post-operation(9 months)
Change of lowest oxygen saturation from baseline to 12 months post-operation(12 months)
Change of lowest oxygen saturation from baseline to 18 months post-operation(18 months)
Change of lowest oxygen saturation from baseline to 24 months post-operation(24 months)
Change of mean oxygen saturation from baseline to 3 months post-operation(3 months)
Change of mean oxygen saturation from baseline to 6 months post-operation(6 months)
Change of mean oxygen saturation from baseline to 9 months post-operation(9 months)
Change of mean oxygen saturation from baseline to 12 months post-operation(12 months)
Change of mean oxygen saturation from baseline to 18 months post-operation(18 months)
Change of mean oxygen saturation from baseline to 24 months post-operation(24 months)
Change of SCOPA-AUT from baseline to 3 months post-operation(3 months)
Change of SCOPA-AUT from baseline to 6 months post-operation(6 months)
Change of SCOPA-AUT from baseline to 9 months post-operation(9 months)
Change of SCOPA-AUT from baseline to 12 months post-operation(12 months)
Change of SCOPA-AUT from baseline to 18 months post-operation(18 months)
Change of SCOPA-AUT from baseline to 24 months post-operation(24 months)
Change of delta cerebral artery velocity from baseline to 3 months post-operation(3 months)
Change of delta cerebral artery velocity from baseline to 6 months post-operation(6 months)
Change of delta cerebral artery velocity from baseline to 9 months post-operation(9 months)
Change of delta cerebral artery velocity from baseline to 12 months post-operation(12 months)
Change of delta cerebral artery velocity from baseline to 18 months post-operation(18 months)
Change of delta cerebral artery velocity from baseline to 24 months post-operation(24 months)
Change of TUG from baseline to 3 months post-operation(3 months)