Health TrialsbyHealthPanel

Spinal Cord Stimulation for Parkinsonism

ConditionParkinsonism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorRuijin Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Pregnancy

History of alcoholism

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Spinal cord stimulation

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: Spinal cord stimulation(SCS) implantationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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.

Time frame
3 months
2

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

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.

Time frame
6 months
3

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

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.

Time frame
9 months
4

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

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.

Time frame
12 months

Secondary outcomes

1

Change of oxygen desaturation index from baseline to 3 months post-operation

Change of oxygen desaturation index measured by on-off polysomnography from baseline to 3 months post-operation

Time frame
3 months
2

Change of oxygen desaturation index from baseline to 6 months post-operation

Change of oxygen desaturation index measured by on-off polysomnography from baseline to 6 months post-operation

Time frame
6 months
3

Change of oxygen desaturation index from baseline to 9 months post-operation

Change of oxygen desaturation index measured by on-off polysomnography from baseline to 9 months post-operation

Time frame
9 months
4

Change of oxygen desaturation index from baseline to 12 months post-operation

Change of oxygen desaturation index measured by on-off polysomnography from baseline to 12 months post-operation

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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