Parkinson's DiseaseNCT07790094
Segmental Laser Acupuncture for Constipation and Sleep in Patients With Parkinson's Disease
A study testing TI-816-3E3 Portable Laser Phototherapy Device in people with Parkinson's Disease, run by China Medical University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- TI-816-3E3 Portable Laser Phototherapy Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Sep 2026to 31 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Presence of urinary or gastrointestinal stones.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
China Medical University Hospital
Taichung, Taichung City, 404327
Yu-Chen Lee, 886-4-2205-3366 ext. 3500, 005167@tool.caaumed.org.tw
Yu-Chen Lee
About this study
Official title: Segmental Laser Acupuncture at T10-L2 and S2-S4 for Gut-Brain Axis Modulation in Parkinson's Disease: A Randomized Double-Blind Clinical Trial on Constipation and Sleep Outcomes
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.
Read more
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
- Being tested
- TI-816-3E3 Portable Laser Phototherapy Device, TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²)
- Keywords
- Parkinson's Disease, Segmental Laser Acupuncture, Brain-gut axis, Constipation, sleep
- Medical subject headings
- Parkinson Disease, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TI-816-3E3 Portable Laser Phototherapy DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Laser Acupuncture Group | Experimental | Participants receive segmental laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol. Receives: 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. Receives: Device: TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: Week 0, Week 4, and Week 8
Secondary outcomes (2)
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Change in sleep disturbance assessed using the Parkinson's Disease Sleep Scale-2 (PDSS-2), a disease-specific questionnaire for patients with Parkinson's disease. The PDSS-2 assesses nocturnal motor symptoms, such as difficulty turning in bed and tremor, rapid eye movement (REM)-related symptoms, and daytime sleepiness, thereby reflecting changes in overall sleep quality following the intervention. Higher scores indicate greater sleep disturbance.
Measured: Week 0, Week 4, and Week 8
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score
The RBDSQ is used to screen for symptoms suggestive of REM sleep behavior disorder (RBD) and to characterize baseline RBD-related features. RBDSQ results will be used for prespecified subgroup analyses to investigate whether the presence or absence of RBD affects the therapeutic efficacy of segmental laser acupuncture.
Measured: Week 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start1 Sep 2026 (estimated)
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Chen Lee, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790094
- Sponsor's protocol ID
- CMUH115-REC3-116
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2026
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Segmental Laser Acupuncture at T10-L2 and S2-S4 for Gut-Brain Axis Modulation in Parkinson's Disease: A Randomized Double-Blind Clinical Trial on Constipation and Sleep Outcomes
- ClinicalTrials.gov ID
- NCT07790094
- Acronym / sponsor ID
- CMUH115-REC3-116
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease, Segmental Laser Acupuncture, Brain-gut axis, Constipation, sleep
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2027 (estimated)
- First posted
- 27 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Laser Acupuncture Group | Experimental | Device: TI-816-3E3 Portable Laser Phototherapy DeviceParticipants receive segmental laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol. |
| Sham Laser Acupuncture Group | Sham comparator | Device: TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²)Participants receive sham laser acupuncture at the T10-L2 and S2-S4 regions according to the study protocol. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TI-816-3E3 Portable Laser Phototherapy DeviceSegmental 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. | Device | Laser Acupuncture Group |
| TI-816-3E3 Portable Laser Phototherapy Device - Sham (0 J/cm²)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. | Device | Sham Laser Acupuncture Group |
Primary outcome
Change in Constipation Scoring System (CSS; Agachan score)
Time frame: Week 0, Week 4, and Week 8
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.
Change in Bristol Stool Form Scale (BSFS) score
Time frame: Week 0, Week 4, and Week 8
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).
2 secondary outcomes
Change in Parkinson's Disease Sleep Scale-2 (PDSS-2) score
Time frame: Week 0, Week 4, and Week 8
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) score
Time frame: Week 0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TI-816-3E3 Portable Laser Phototherapy Device in people with Parkinson's Disease, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jen-Hsuan Yeh (886-900295568, rensyuan86@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Constipation Scoring System (CSS; Agachan score) (time frame: Week 0, Week 4, and Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.