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New device targets apathy in Parkinson's: a simple stimulation might boost motivation

NCT ID NCT07118956

Symptom relief Sponsor: Anhui Medical University Source: ClinicalTrials.gov ↗

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a non-invasive device that stimulates the vagus nerve in the ear, timed with breathing, to see if it can reduce apathy (lack of motivation) in people with Parkinson's disease. 60 participants will receive either the real stimulation or a sham (fake) version for 2 weeks. Researchers will measure changes in motivation, other non-motor symptoms, and check for side effects.

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.

Started

May 2025

Expected to finish

May 2028

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

40 to 90 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: 1. Meet the diagnostic criteria for idiopathic Parkinson's disease (based on the MDS Clinical Diagnostic Criteria for Parkinson's Disease (2015 version)). 2. Patients with Apathy Motivation Index (AMI) score \>1.7. 3. All PD patients must be on stable, standardized medication regimens with no adjustments to medications for at least 1 month prior to the study and throughout the study period. 4. Demonstrate good compliance and adherence, capable of completing behavioral tests and taVNS therapy. 5. Mini-Mental State Examination (MMSE) score ≥22. 6. Meet safety criteria for MRI screening. Exclusion Criteria: 1. Prior brain MRI/CT showing focal brain lesions or severe white matter disease (Fazekas grade 3 or higher). 2. Secondary parkinsonism (e.g., vascular parkinsonism, drug-induced parkinsonism). 3. History of severe traumatic brain injury, neurosurgery, or deep brain stimulation (DBS) therapy. 4. Personal history of epilepsy, unexplained loss of consciousness, or current use of anticonvulsant medications for seizure control. 5. Diagnosis of neuropsychiatric disorders other than Parkinson's disease. 6. Current use of non-steroidal anti-inflammatory drugs (NSAIDs) or Non-benzodiazepine GABA receptor agonist drug or anticholinergics or corticosteroids, or history of substance abuse or drug addiction. 7. Participation in any clinical trial within the past 3 months. 8. Severe systemic comorbidities (e.g., hepatic/renal failure, arrhythmias, organic heart disease). 9. Pregnant/lactating women or subjects (including males) planning pregnancy within 6 months. 10. Contraindications to taVNS, such as cardiac pacemakers, post-DBS surgery, or auricular pathologies (e.g., tympanic membrane perforation).

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Conditions

The condition(s) this trial relates to.

Lethargy Parkinson disease

As listed by the trial registrant

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

APATHY Non-motor symptoms Parkinson disease Vagus nerve stimulation

How to take part

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  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

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Contacts and locations

Locations

  • Cognitive Neuropsychology Lab Anhui Medical University

    RECRUITING

    Hefei, Anhui, 230022, China

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