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

NCT07790094 | Not Yet Recruiting

• 1 other identifier: CMUH115-REC3-116
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson's Disease

Keywords

Parkinson's Disease; Segmental Laser Acupuncture; Brain-gut axis; Constipation; sleep

Outcome Measures

Primary Outcomes (2)

• Change in Constipation Scoring System (CSS; Agachan score)

  Change in constipation severity assessed using the Constipation Scoring System (CSS; Agachan score). The CSS consists of 8 items assessing bowel movement frequency, difficulty, sensation of incomplete evacuation, abdominal pain, time spent on the toilet, and use of assistance for bowel evacuation. Scores range from 0 to 30, with higher scores indicating more severe constipation.

  Week 0, Week 4, and Week 8

• Change in Bristol Stool Form Scale (BSFS) score

  Change in stool form assessed using the Bristol Stool Form Scale (BSFS), which classifies stool consistency into seven types ranging from hard stool to watery stool (Type1 to Type7).

  Week 0, Week 4, and Week 8

Secondary Outcomes (2)

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

  Week 0, Week 4, and Week 8

• REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score

  Week 0

Other Outcomes (2)

• Change in salivary cortisol level

  Week 0, Week 4, and Week 8

• Change in salivary alpha-amylase (sAA) level

  Week 0, Week 4, and Week 8

Study Arms (2)

Laser Acupuncture Group

EXPERIMENTAL

Participants receive segmental laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol.

Device: TI-816-3E3 Portable Laser Phototherapy Device

Sham Laser Acupuncture Group

SHAM COMPARATOR

Participants receive sham laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol.

Device: TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²)

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.

Laser Acupuncture Group

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.

Sham Laser Acupuncture Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of Parkinson's disease by a neurologist according to the Movement Disorder Society (MDS) clinical diagnostic criteria.
• Coexisting chronic constipation meeting the Rome IV diagnostic criteria. Age ≥ 50 years.
• Stable dosage of anti-Parkinson's medications for at least 4 weeks prior to study enrollment.
• Ability to understand the study procedures, provide written informed consent, and comply with scheduled visits and study assessments.

You may not qualify if:

• Organic gastrointestinal diseases, such as gastrointestinal malignancy, intestinal obstruction, or inflammatory bowel disease.
• Severe cognitive impairment, including dementia that significantly interferes with study participation, or severe psychiatric disorders that affect compliance.
• Severe skin infection or open wounds at the treatment sites, including the thoracolumbar or sacral regions.
• Implanted electronic medical devices, such as cardiac pacemakers or deep brain stimulation (DBS) devices, unless deemed eligible after appropriate safety evaluation.
• Recent initiation or significant dose adjustment of medications that may affect gastrointestinal motility.
• Photosensitivity disorders or use of medications with significant photosensitizing effects.
• Significant dermatological diseases or skin cancer.
• Systemic lupus erythematosus.
• Acute illness at the time of enrollment.
• Abnormal blood pressure or fever at the time of treatment or enrollment.
• Active or untreated malignancy.
• Pregnancy.
• Significant physical abnormalities or sensory neurological abnormalities that may affect the safety or assessment of the intervention.
• Active infectious diseases.
• Coagulation disorders or clinically significant bleeding disorders.

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, Taichung City, 404327, Taiwan

Location

MeSH Terms

Conditions

Parkinson Disease; Constipation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jen-Hsuan Yeh

CONTACT

886-900295568; rensyuan86@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Acupuncture

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)