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Can a zapping helmet ease Parkinson's tremors and speech problems?

NCT ID NCT07721688

Disease control Sponsor: Ke Dong, MD Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 23, 2026 · Last updated Aug 12, 2026 · Updated 3 times

Summary

This trial investigates whether a non-invasive brain stimulation technique called temporal interference stimulation (TIS) can improve motor and speech function in people with Parkinson's disease. TIS uses two high-frequency electrical fields to precisely target deep brain regions without surgery. Sixty participants with mild-to-moderate Parkinson's will receive either real TIS or a sham (placebo) stimulation over five days. Researchers will measure changes in movement, balance, and speech, and use fMRI to track brain activity changes.

What this could mean

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

Active substance
temporal interference stimulation (TIS) — a non-invasive brain stimulation device
What this could lead to
If effective, TIS could offer a non-invasive, drug-free option to improve movement and speech in Parkinson's disease.
What could go wrong
This is an early-stage trial with 60 participants, so results may not apply broadly. The sham-controlled design means some may receive no benefit, and individual responses may vary.

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 40 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. Idiopathic Parkinson's disease diagnosed by neurologists according to the Movement Disorder Society Clinical Diagnostic Criteria; 2. Hoehn and Yahr stage 1.5-3.0; 3. Stable levodopa-based antiparkinsonian medication for at least 4 weeks before enrolment, with no planned medication change during the trial period; 4. Ability to walk independently; 5. Ability to understand and follow study instructions and complete the required assessments, with no severe cognitive impairment as screened by the Montreal Cognitive Assessment and/or Mini-Mental State Examination according to prespecified thresholds; 6. Willingness to participate and provide written informed consent. Exclusion Criteria: 1. Any contraindication to MRI or tTIS, including claustrophobia or ferromagnetic intracranial or subcutaneous implants; 2. Significant systemic disease that could increase study risk or interfere with trial participation; 3. Neurological disorders other than Parkinson's disease; 4. Major psychiatric disorder or severe depression or anxiety; 5. History of deep brain stimulation surgery; 6. Inability or unwillingness to complete all interventions and assessments.

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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 (PD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Department of Rehabilitation Medicine, The First Affiliated Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510000, China

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