Clinical trial NCT05171205: Spinal Cord Stimulation for Parkinsonism
Official title: Spinal Cord Stimulation for Parkinsonism: a Single-center, Single-arm Open Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinsonism
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2021-12-28
Enrollment: 50
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change of blood pressure from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of blood pressure from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of blood pressure from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of blood pressure from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of blood pressure from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of blood pressure from baseline to 24 months post-operation
timeFrame: 24 months
Secondary outcomes:
measure: Change of oxygen desaturation index from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of oxygen desaturation index from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of oxygen desaturation index from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of oxygen desaturation index from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of oxygen desaturation index from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of oxygen desaturation index from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of apnea hypopnea index from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of apnea hypopnea index from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of apnea hypopnea index from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of apnea hypopnea index from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of apnea hypopnea index from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of apnea hypopnea index from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of on-off 24-hour blood pressure monitoring from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of on-off 24-hour blood pressure monitoring from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of on-off 24-hour blood pressure monitoring from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of on-off 24-hour blood pressure monitoring from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of on-off 24-hour blood pressure monitoring from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of on-off 24-hour blood pressure monitoring from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of on-off time patient spend in supine status, seated status, standing/walking status from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of serum catecholamine neurotransmitter levels from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of serum catecholamine neurotransmitter levels from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of serum catecholamine neurotransmitter levels from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of serum catecholamine neurotransmitter levels from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of serum catecholamine neurotransmitter levels from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of serum catecholamine neurotransmitter levels from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of on-off delta heart rate variability from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of on-off delta heart rate variability from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of on-off delta heart rate variability from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of on-off delta heart rate variability from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of on-off delta heart rate variability from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of on-off delta heart rate variability from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of length of walking during 6-minute walking test from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of length of walking during 6-minute walking test from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of length of walking during 6-minute walking test from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of length of walking during 6-minute walking test from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of length of walking during 6-minute walking test from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of length of walking during 6-minute walking test from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of time of walking during 6-minute walking test from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of time of walking during 6-minute walking test from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of time of walking during 6-minute walking test from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of time of walking during 6-minute walking test from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of time of walking during 6-minute walking test from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of time of walking during 6-minute walking test from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of on-off numbers of mistakes made during Stroop Color and Word Test from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of on-off time to complete the Stroop Color and Word Test from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of on-off time to complete the Stroop Color and Word Test from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of on-off time to complete the Stroop Color and Word Test from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of on-off time to complete the Stroop Color and Word Test from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of on-off time to complete the Stroop Color and Word Test from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of on-off time to complete the Stroop Color and Word Test from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of on-off delta brain cortex oxygenated hemoglobin levels from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of dysarthria symptom from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of dysarthria symptom from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of dysarthria symptom from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of dysarthria symptom from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of dysarthria symptom from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of dysarthria symptom from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of urinary retention from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of urinary retention from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of urinary retention from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of urinary retention from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of urinary retention from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of urinary retention from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of MDS-UPDRS from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of MDS-UPDRS from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of MDS-UPDRS from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of MDS-UPDRS from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of MDS-UPDRS from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of MDS-UPDRS from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of UMSARS from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of UMSARS from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of UMSARS from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of UMSARS from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of UMSARS from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of UMSARS from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of lowest oxygen saturation from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of lowest oxygen saturation from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of lowest oxygen saturation from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of lowest oxygen saturation from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of lowest oxygen saturation from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of lowest oxygen saturation from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of mean oxygen saturation from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of mean oxygen saturation from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of mean oxygen saturation from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of mean oxygen saturation from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of mean oxygen saturation from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of mean oxygen saturation from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of SCOPA-AUT from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of SCOPA-AUT from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of SCOPA-AUT from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of SCOPA-AUT from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of SCOPA-AUT from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of SCOPA-AUT from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of delta cerebral artery velocity from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of delta cerebral artery velocity from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of delta cerebral artery velocity from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of delta cerebral artery velocity from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of delta cerebral artery velocity from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of delta cerebral artery velocity from baseline to 24 months post-operation
timeFrame: 24 months
measure: Change of TUG from baseline to 3 months post-operation
timeFrame: 3 months
measure: Change of TUG from baseline to 6 months post-operation
timeFrame: 6 months
measure: Change of TUG from baseline to 9 months post-operation
timeFrame: 9 months
measure: Change of TUG from baseline to 12 months post-operation
timeFrame: 12 months
measure: Change of TUG from baseline to 18 months post-operation
timeFrame: 18 months
measure: Change of TUG from baseline to 24 months post-operation
timeFrame: 24 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Neurology and Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Jun Liu, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: