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Can a Split-Target brain implant beat standard DBS for Parkinson's gait trouble?

NCT ID NCT05397340

Symptom relief Sponsor: Ruijin Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
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 This study
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 Results may not be published yet.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
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 22, 2026 · Last updated Sep 23, 2026 · Updated 1 time

Summary

Researchers are testing whether deep brain stimulation aimed at two different brain targets works better than the standard bilateral approach for Parkinson's disease patients who have trouble with balance and walking. The trial enrolls 40 people with Parkinson's who show postural instability and gait difficulty. Participants receive either asymmetric stimulation, with one electrode in the subthalamic nucleus and the other in the globus pallidus interna, or standard bilateral subthalamic nucleus stimulation. Neither participants nor evaluators know which treatment each person receives. The study measures changes in movement symptoms, balance, and freezing episodes over 12 months.

What this could mean

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

Active substance
deep brain stimulation, a surgical treatment that implants electrodes to send electrical pulses into specific brain regions
What this could lead to
If the asymmetric approach works better, doctors could tailor DBS surgery to each patient's most troublesome symptoms, potentially improving balance and walking for people whose Parkinson's does not respond well to standard stimulation.
What could go wrong
This is a small trial of 40 people at a single hospital, so results may not apply broadly. Brain surgery carries risks of bleeding, infection, and device problems, and the asymmetric target approach is still experimental for gait and balance symptoms.

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

40 people

The number who actually took part.

Started

Sep 2022

Finished

Nov 2025

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

18 to 75 years

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 idiopathic Parkinson's disease * postural instability/gait difficulty (PIGD) phenotypes in both off- and on-medication condition Exclusion Criteria: * Atypical parkinsonism * History of stroke, encephalitis, neuroleptic uses, MRI scan with evidence of significant brain atrophy, lacunar infracts, or other conditions that might interfere with intracranial surgery * Presence of cognitive, or psychiatric or other co-morbidities (e.g., dementia, epilepsy, cranial traumatism, brain tumor, schizophrenia, severe depression or bipolar disorder, personality disorder, etc.) that might interfere with the patient's ability to complete the evaluations or to provide informed consent * Presence of anatomical abnormalities in the target region * Clinically significant medical history that would increase pre-/post-operative complications * Other conditions considered by the investigators that might interfere with the surgery procedure, the follow-ups, and the interpretation of the data

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Conditions

The condition(s) this trial relates to.

Parkinson disease

As listed by the trial registrant

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

Parkinson disease

Contacts and locations

Locations

  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

    Shanghai, China

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