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Brain pacemaker learns to help Parkinson's patients walk better

NCT ID NCT04675398

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tests a new type of deep brain stimulation that adapts in real time to a person's movements, aiming to improve walking and motor skills in Parkinson's disease. Ten patients already scheduled for standard DBS surgery will receive this adaptive stimulation and be compared to standard continuous stimulation. The goal is to see if personalized, on-demand stimulation can improve gait and reaction times better than current methods.

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 device (Summit RC+S)
What this could lead to
If successful, this could lead to a more personalized, on-demand brain stimulation therapy that improves walking and movement in people with Parkinson's disease.
What could go wrong
This is a very early, small study with only 10 participants. It is testing a new stimulation pattern, not a cure, and may not show clear benefits or work for everyone.

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 10 people

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

Started

Jun 2021

Expected to finish

Apr 2030

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

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: * Ability to give informed consent for the study * Movement disorder symptoms that are sufficiently severe, in spite of best medical therapy, to warrant surgical implantation of deep brain stimulators according to standard clinical criteria * Patient has requested surgical intervention with deep brain stimulation for their disorder * No movement -elated abnormalities that suggest an alternative diagnosis or contraindicate surgery * Absence of significant cognitive impairment (score of 21 or greater on the Montreal Cognitive Assessment (MoCA), * Signed informed consent * Ability to comply with study follow-up visits for brain recording, testing of adaptive stimulation, and clinical assessment. * Age 21-75 * Diagnosis of idiopathic PD with duration of motor symptoms for 3 years or greater * Patient has undergone appropriate therapy with oral medications with inadequate relief as determined by a movement disorders neurologist. * UPDRS-III score off medication between 20 and 80 and an improvement of at least 30% in the baseline UPDRS-III on medication score, compared to the baseline off-medication score, and motor fluctuations with at least 2 hours per day of on time without dyskinesia or with non-bothersome dyskinesia. OR Patients with tremor-dominant PD (a tremor score of at least 2 on a UPDRS-III sub-score for tremor), treatment resistant, with significant functional disability despite maximal medical management * Patients with gait impairments: slowed gait, shuffling steps, postural instability, or freezing of gait off medication. * Ability of patient and/or caregivers to recharge the system evaluated by all clinicians and study personnel. * Geographical proximity and/or ability to travel to study sites for patient to receive re-programming via investigational devices (e.g. Summit Research Laboratory Programmer). Exclusion Criteria: * Coagulopathy, anticoagulant medications, uncontrolled hypertension, history of seizures, heart disease, or other medical conditions considered to place the patient at elevated risk for surgical complications * Evidence of a psychogenic movement disorder: Motor symptoms that remit with suggestion or "while unobserved", symptoms that are inconsistent over time or incongruent with clinical condition, plus other manifestation such as "false" signs, multiple somatizations, or obvious psychiatric disturbance. * Pregnancy: all women of child bearing potential will have a negative urine pregnancy test prior to undergoing their surgical procedure. * Significant untreated depression (BDI-II score \>20). History of suicidal attempt or active suicidal ideation (Yes to #2-5 on C-SSRS) * Any personality or mood symptoms that study personnel believe will interfere with study requirements. * Subjects who require electroconvulsive therapy (ECT), repetitive transcranial magnetic stimulation (rTMS) or diathermy * Implanted stimulation systems such as; cochlear implant, pacemaker, defibrillator, or neurostimulator * Previous cranial surgery * Drug or alcohol abuse * Meets criteria for Parkinson's disease with mild cognitive impairment (PD-MCI). These criteria are: performance of more than two standard deviations below appropriate norms, for tests from two or more of these five cognitive domains: attention, executive function, language, memory, and visuospatial tests. * Known allergies to the implantable device components including titanium, polyurethane, silicone, and nylon.

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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.

Contacts and locations

Locations

  • UCSF

    San Francisco, California, 94134, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.