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Brain stimulator that thinks on its feet shows promise for Parkinson's freezing

NCT ID NCT04043403

Disease control Sponsor: Stanford University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested a new type of deep brain stimulation (DBS) that adapts in real time to help people with Parkinson's disease who experience freezing of gait—a sudden inability to move their feet. Standard DBS delivers constant stimulation, but this adaptive system uses brain signals or leg movement sensors to adjust stimulation as needed. Twelve participants were enrolled to see if the approach is safe and feasible.

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 (DBS) device that adjusts stimulation based on brain signals or movement
What this could lead to
If successful, this approach could lead to a more responsive DBS system that reduces freezing episodes and improves mobility for people with Parkinson's.
What could go wrong
This was a small feasibility study with only 12 participants, so results may not apply to everyone. The adaptive system is still experimental and may not work better than standard DBS.

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

12 people

The number who actually took part.

Started

Oct 2019

Finished

Aug 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 80 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: * Clinically-established PD * Meets criteria for STN DBS eligibility as part of patient's standard medical care or already implanted in the STN with Percept(TM) PC * The presence of complications of medication such as wearing off signs, fluctuating responses and/or dyskinesias, and/or medication refractory tremor, and/or impairment in the quality of life on or off medication due to these factors. * Ability and willingness to return for study visits, at the initial programming and after three, six and twelve months of DBS. * Age \> 18 * Freezing of gait questionnaire (FOG-Q) score ≥ 1 and/or gait sub-score (Item 3.10) of MDS- UPDRS III ≥ 1 * Greater than or equal to 1.2 microVp between 8-35 Hz on either the LSTN or RSTN (Percept (TM) PC cohort only) Exclusion Criteria: * Dementia * Untreated psychiatric disease * Hoehn and Yahr stage 5 on or off medication (non-ambulatory) * Age \> 80 * Major surgical morbidities such as severe hypertension, coagulopathy and certain metabolic conditions that might increase the risk of hemorrhage or other surgical complications * Presence of a cardiac pacemaker/defibrillator * Inability to understand/sign consent * Requires rTMS, ECT, MRI (Summit(R) RC+S cohort only), or diathermy * Are pregnant or lactating * Has a cranial metallic implant * History of seizures or epilepsy

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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

  • Stanford University

    Stanford, California, 94305, United States

More trials for these conditions

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