NCT07790094Toborzás még nem indult
Segmental Laser Acupuncture for Constipation and Sleep in Patients With Parkinson's Disease
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
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 27.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Toborzás még nem indult
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 60 (tervezett)
- Első benyújtás
- 2026. aug. 24.
- Kezdés
- 2026. szept. 1.
- Elsődleges befejezés
- 2027. aug. 31.
- Fő szponzor
- China Medical University Hospital
- Betegségek
- Parkinson-kór
- NCT-szám
- NCT07790094
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó
- Tervezett résztvevők: 60
- 2026. szept. 1. és az elsődleges befejezés (2027. aug. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Korábbi kezelés
- Recent initiation or significant dose adjustment of medications that may affect gastrointestinal motility.
Más betegség
- 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.
- Photosensitivity disorders or use of medications with significant photosensitizing effects.
- Significant dermatological diseases or skin cancer.
- Acute illness at the time of enrollment.
- Active or untreated malignancy.
- Active infectious diseases.
- Coagulation disorders or clinically significant bleeding disorders.
Egyéb
- Systemic lupus erythematosus.
- Abnormal blood pressure or fever at the time of treatment or enrollment.
- Pregnancy.
- Significant physical abnormalities or sensory neurological abnormalities that may affect the safety or assessment of the intervention.
- Presence of urinary or gastrointestinal stones.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 50 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| China Medical University Hospital Ennek a helyszínnek vagy a koordinátora? Erősítsd meg az állapotát | Taichung | Tajvan | Ismeretlen állapot |
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