Segmental Laser Acupuncture for Constipation and Sleep in Patients With Parkinson's Disease

Sponsor
China Medical University Hospital
Study ID
NCT07790094
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • TI-816-3E3 Portable Laser Phototherapy Device — DEVICE
    Segmental laser acupuncture is administered using the TI-816-3E3 Portable Laser Phototherapy Device at the T10-L2 and S2-S4 regions. The device is applied in contact mode, with a power density of 100 mW/cm² and a treatment dose of 6 J/cm² per application. Each treatment session lasts 60 seconds. Treatment is administered twice weekly for 8 weeks.
  • TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²) — DEVICE
    Sham segmental laser acupuncture is administered using the TI-816-3E3 Portable Laser Phototherapy Device at the T10-L2 and S2-S4 regions. The device is applied in contact mode with a power density of 0 mW/cm² and a treatment dose of 0 J/cm² per application. The sham procedure provides visible light and is designed to be identical to the active treatment in terms of device operation, treatment procedure, treatment duration, and participants' sensory experience. Each treatment session lasts 60 seconds. Treatment is administered twice weekly for 8 weeks. No therapeutic laser energy is delivered.

Study Details

Parkinson's disease (PD) is characterized not only by motor symptoms but also by common and clinically significant non-motor symptoms, including constipation and sleep disturbances, which can substantially impair quality of life. The concept of the "gut-brain axis" describes bidirectional communication among the central nervous system, autonomic nervous system, enteric nervous system, and gut microbiota. Increasing evidence from animal models suggests that the gut-brain axis may play an important role in the pathophysiology and progression of PD. Given the central role of autonomic nervous system regulation in the gut-brain axis, this study will use laser acupuncture as a safe, non-invasive form of photobiomodulation (PBM) with potential neuromodulatory effects. Based on the concept of segmental neuromodulation, laser stimulation will be applied to the thoracolumbar paraspinal regions (T10-L2) and sacral segments (S2-S4, corresponding to the Baliao points) to modulate sympathetic activity arising from T10-L2 and pelvic parasympathetic activity arising from S2-S4. This approach is intended to promote intestinal motility and defecation reflexes. Meanwhile, by modulating autonomic balance and stabilizing stress-sleep rhythms, as assessed by salivary biomarkers including salivary cortisol and salivary alpha-amylase (sAA), the intervention is expected to improve sleep quality in patients with PD. This study is designed as a randomized, double-blind, sham-controlled clinical trial. Participants with PD who experience constipation will be recruited and undergo an 8-week intervention. The primary outcomes will assess changes in constipation symptoms using the Bristol Stool Form Scale (BSFS) and the Constipation Scoring System (CSS; Agachan Score). Secondary outcomes will assess sleep quality using the Parkinson's Disease Sleep Scale-2 (PDSS-2) and the REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ). Objective salivary biomarkers, including salivary cortisol and sAA, will also be measured to investigate changes in autonomic function and their associations with improvements in clinical symptoms. This study is expected to provide preliminary evidence regarding the potential role of segmental laser acupuncture in modulating the gut-brain axis and improving non-motor symptoms in patients with PD, thereby providing a basis for future larger-scale studies and the development of clinical care strategies.

Key Dates

First listed
Aug 27, 2026
Start date
Sep 1, 2026
Status verified
Aug 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Laser Acupuncture Group
    Participants receive segmental laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol.
  • Sham Comparator: Sham Laser Acupuncture Group
    Participants receive sham laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol.

Primary Outcome Measure

Change in Constipation Scoring System (CSS; Agachan score) [ Time Frame: Week 0, Week 4, and Week 8 ]

Central Contacts

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