Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease
Recruiting · NCT07299240 · Interventional (participants receive a specific treatment) · Lead sponsor: Jiangsu Province Nanjing Brain Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- The Affiliated Brain Hospital of Nanjing Medical University, 264 Guangzhou Road - Nanjing, Jiangsu, China