Laser acupuncture targets the gut-brain axis to tackle Parkinson's constipation and sleep troubles

NCT ID NCT07790094

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
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Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 27, 2026 · Last updated Aug 28, 2026 · Updated 1 time

Summary

This trial tests whether laser acupuncture, a non-invasive treatment using light on specific back points, can ease constipation and improve sleep in people with Parkinson's disease. The study includes 60 participants with Parkinson's and constipation, who will receive either real or sham laser treatment twice a week for 8 weeks. Researchers will measure changes in constipation severity, stool form, sleep quality, and stress-related saliva markers to see if the treatment helps regulate the gut-brain axis.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Laser acupuncture using the TI-816-3E3 Portable Laser Phototherapy Device, applied to the lower back and sacral areas
What this could lead to
If it works, this could offer a safe, non-invasive way to ease constipation and improve sleep in people with Parkinson's disease, potentially improving quality of life.
What could go wrong
This is a small, early-stage trial with 60 participants, so results may not apply to everyone. The sham control helps, but the effect may be modest or not last beyond the 8-week treatment period.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Presence of urinary or gastrointestinal stones.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • China Medical University Hospital

    Taichung, Taichung City, 404327, Taiwan

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