NCT07572903

Brief Summary

This study aimed to evaluate the clinical efficacy and safety of temporal interference stimulation (TIS) targeting different targets in patients with Parkinson's disease (PD), and to investigate the associated neurophysiological mechanisms. A three-arm, randomised, double-blind, parallel-group design was employed, consisting of a right globus pallidus internus (GPi) stimulation group, a right subthalamic nucleus (STN) stimulation group, and a sham stimulation group. PD patients in the OFF-medication state (≥12 hours after the last dopaminergic dose) were randomly assigned to receive either active TIS targeting the GPi or STN, or sham stimulation, with each session lasting 30 minutes. Clinical symptom assessments were conducted before and immediately after the intervention, and safety was monitored throughout by the research team.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 27, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 6, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2026

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

August 11, 2026

Status Verified

July 1, 2026

Enrollment Period

2 months

First QC Date

April 27, 2026

Last Update Submit

August 8, 2026

Conditions

Parkinson s Disease

Keywords

Parkinson s DiseaseTemporal Interference Stimulation

Outcome Measures

Primary Outcomes (1)

  • The part III of MDS-Unified Parkinson's Disease Rating Scale

    Baseline，Immediately after a single stimulation

Secondary Outcomes (7)

  • Hoehn-Yahr Stage Scale

    Baseline，Immediately after a single stimulation

  • 3-Meter Timed Up and Go Test

    Baseline，Immediately after a single stimulation

  • 10-meter walking test

    Baseline，Immediately after a single stimulation

  • Upper and lower limb alternation

    Baseline，Immediately after a single stimulation

  • Clinical Global Impression

    Baseline，Immediately after a single stimulation

  • +2 more secondary outcomes

Study Arms (3)

GPi group

EXPERIMENTAL
Other: Temporal Interference Stimulation

STN group

EXPERIMENTAL
Other: Temporal Interference Stimulation

Sham group

SHAM COMPARATOR
Other: Temporal Interference Stimulation

Interventions

Temporal Interference StimulationOTHER

Temporal Interference Stimulation

GPi groupSTN groupSham group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age \>= 40 years;
  • Meet the diagnostic criteria for primary Parkinson's disease (MDS Parkinson's Disease Diagnostic Criteria (2015 Edition));
  • No medication adjustment in the 4 weeks before and during each stimulation;
  • MDS-UPDRS III score \>= 8 points, Hoehn-Yahr score 1-4 points

You may not qualify if:

  • Focal brain injury or severe leukoencephalopathy (Fazekas grade 3 or above) on previous head MRI/CT scans;
  • Various secondary Parkinson's syndromes (vascular Parkinson's syndrome, drug-induced Parkinson's syndrome, etc.);
  • Severe craniocerebral trauma, cranial surgery or deep brain stimulation treatment;
  • Ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.;
  • A history of epilepsy, unexplained loss of consciousness, or taking anticonvulsant drugs for epileptic seizures;
  • Diagnosed with neuropsychiatric diseases other than Parkinson's disease;
  • A history of drug abuse or drug use;
  • Participated in any clinical trial in the past 3 months;
  • Pregnant/lactating women or subjects (including men) who plan to have children within 6 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Neurology Department, The First Affiliated Hospital of Anhui Medical University

Study Record Dates

First Submitted

April 27, 2026

First Posted

May 7, 2026

Study Start

May 6, 2026

Primary Completion

July 16, 2026

Study Completion

August 1, 2026

Last Updated

August 11, 2026

Record last verified: 2026-07

Locations

CN(1)