Remote Ischemic Conditioning for Sleep Disturbances and Other Non-motor Symptoms in Parkinson's Disease

NCT07299240 | Not Yet Recruiting DMC

• 1 other identifier: 2024-KY088-02
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease (PD); Insomnia

Keywords

remote ischemic conditioning; Parkinson's disease; insomnia; non-motor symptoms

Outcome Measures

Primary Outcomes (1)

• Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) total score

  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.

  From baseline to 7 days after the start of RIC

Secondary Outcomes (2)

• Change in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score (0-260 points; higher scores indicate worse motor and non-motor symptoms).

  Baseline to 7 days after RIC

• Change in Montreal Cognitive Assessment (MoCA) total score (0-30 points; higher scores indicate better cognitive function).

  Baseline to 7 days after RIC

Study Arms (2)

Active RIC group

EXPERIMENTAL

Participants receive active remote ischemic conditioning plus standard antiparkinsonian medications.

Device: Remote ischemic conditioning device

Sham RIC group

SHAM COMPARATOR

Participants receive sham remote ischemic conditioning (low-pressure cuff inflation) plus standard antiparkinsonian medications.

Device: Sham remote ischemic conditioning

Interventions

Remote ischemic conditioning device 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.

Also known as: RIC training device

Active RIC group

Sham remote ischemic conditioning DEVICE

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.

Sham RIC group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu Province Nanjing Brain Hospital: lead

Study Sites (1)

the Affiliated Brain Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Parkinson Disease; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Mental Disorders

Study Officials

• Haochen Sun

  Department of Neurology, the Affiliated Brain Hospital of Nanjing Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haochen Sun, MD

CONTACT

+86-025-82296261; 735690822@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors are blinded to group allocation. Active and sham RIC devices are identical in appearance, and both groups undergo the same procedures except for cuff inflation pressure.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: December 23, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months and ending 5 years after publication of the main results.
• Access Criteria: Researchers must submit a methodologically sound proposal and sign a data use agreement.

Locations

CN (1)