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Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease
Condition(s) studied
Parkinson Disease (PD)Insomnia
Investigational drug(s) / intervention(s)
Remote ischemic conditioning deviceSham remote ischemic conditioning
Remote ischemic conditioning device: An automated upper-limb cuff device is applied to one arm to induce brief episodes of limb ischemia and reperfusion. In the active RIC group, the cuff is inflated to a high pressure (approximately 200 mmHg) sufficient to occlude arterial blood flow, and then deflated repeatedly according to a pre-set program recommended by the manufacturer. RIC is performed twice daily for 7 consecutive days.
Sham remote ischemic conditioning: The same device and procedure are used as in the active RIC group, but the cuff is inflated only to a low pressure (approximately 60 mmHg) that does not occlude arterial blood flow. Sham RIC is performed twice daily for 7 consecutive days.
Study summary
This single-center, randomized, single-blind, sham-controlled clinical trial aims to evaluate whether remote ischemic conditioning (RIC) can improve sleep disturbances and other non-motor symptoms in patients with Parkinson's disease (PD). Forty-eight PD patients with insomnia will be randomly assigned in a 1:1 ratio to receive either active RIC (cuff inflation to high pressure) or sham RIC (cuff inflation to low pressure) for 7 consecutive days, in addition to their standard antiparkinsonian medications. Subjective sleep scales, sleep diaries, validated rating scales for motor and non-motor symptoms, and overnight polysomnography will be used to assess treatment effects at baseline, after the 7-day intervention, and during short-term follow-up. The study will also explore potential mechanisms of RIC by combining EEG, functional MRI, retinal optical coherence tomography, and blood biomarkers.
Eligibility
Inclusion Criteria:
* Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
* Age between 50 and 70 years.
* Disease duration ≤ 5 years.
* Hoehn and Yahr stage I-III in the "on" state.
* Presence of insomnia that meets the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria and clinically significant sleep complaints (for example, Parkinson's Disease Sleep Scale-2 \[PDSS-2\] total score ≥ 18 points).
* On a stable regimen of antiparkinsonian medications for at least 4 weeks prior to enrollment, with no expected dose changes during the study period.
* Able to understand the study procedures and provide written informed consent (or consent provided by a legally authorized representative when appropriate).
Exclusion Criteria:
* Secondary insomnia due to other severe medical conditions (e.g., uncontrolled cardiopulmonary, hepatic, renal, or endocrine diseases).
* Current psychotic symptoms or severe anxiety or depression (e.g., Hamilton Anxiety Scale score ≥ 14 or Hamilton Depression Scale score ≥ 17).
* Other primary sleep disorders such as moderate-to-severe obstructive sleep apnea, restless legs syndrome, periodic limb movement disorder, or rapid eye movement sleep behavior disorder that require specific treatment.
* History of significant cerebrovascular disease, brain tumor, central nervous system infection, or other neurological disorders that may interfere with sleep or study assessments.
* Contraindications to remote ischemic conditioning (RIC), including severe peripheral arterial disease of the upper limbs, local soft tissue infection or damage at the cuff site, subclavian artery thrombosis, malignant hypertension, severe cardiac disease, active bleeding disorders, or other conditions judged unsafe by the investigator.
* Contraindications to MRI or EEG examinations (e.g., pacemaker, severe claustrophobia, metallic implants incompatible with MRI).
* Participation in another interventional clinical trial within the past 3 months.
* Inability to comply with the study procedures or follow-up visits, as judged by the investigator.
Primary outcome measure(s)
- Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score — From baseline to 7 days after the start of RIC
The PDSS-2 is a 15-item patient-reported questionnaire assessing sleep problems in Parkinson's disease. Total scores range from 0 to 60, with higher scores indicating more severe sleep disturbances. The primary outcome is the change in PDSS-2 total score from baseline to the end of the 7-day RIC or sham RIC intervention.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road |
Nanjing |
Jiangsu |
Recruiting |
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