NCT06931483

Brief Summary

To demonstrate that intervention targeting the right globus pallidus internus (GPi) using transcranial temporal interference stimulation can improve motor symptoms in patients with Parkinson's disease.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2024

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 17, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

1.1 years

First QC Date

April 9, 2025

Last Update Submit

April 9, 2025

Conditions

Temporal Interference StimulationParkinson's Diseasethe Right Globus Pallidus InternusMotor Symptoms

Keywords

temporal interference stimulationParkinson's Diseasemotor symptomsthe right globus pallidus internus

Outcome Measures

Primary Outcomes (1)

  • Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    To assess the motor symptoms, participants completed the official Chinese version of MDS-UPDRS.The MDS-UPDRS-III includes 33 items, with scores ranging from 0 to 132. The subscores of MDS-UPDRS-III, including (1) rigidity (item 3.3), (2) bradykinesia (items 3.2, 3.4, 3.8, and 3.14), (3) tremor (items 3.15-3.18), and (4) axial signs (items 3.9-3.13), were also used as the secondary outcomes in the following analyses.

    On intervention Day 1, Day 10 and 1-month follow-up.

Secondary Outcomes (2)

  • emotional symptoms assessed by the HAMA

    on intervention Day 1, Day 10 and 1-month follow-up

  • emotional symptoms assessed by the HAMD

    On intervention Day 1, Day 10 and 1-month follow-up.

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

Participants will receive active tTIS for 10 days.

Device: Transcranial temporal interference stimulation (tTIS)

sham stimulation

SHAM COMPARATOR

Participants will receive sham tTIS for 10 days.

Device: Sham transcranial temporal interference stimulation (tTIS)

Interventions

Transcranial temporal interference stimulation (tTIS)DEVICE

The total stimulation duration was 30 minutes, including a 30-second current ramp-up at the beginning and a 30-second ramp-down at the end.

real stimulation
Sham transcranial temporal interference stimulation (tTIS)DEVICE

Sham stimulation had only 30 seconds of current ramping-up and ramping-down at the beginning and end of the stimulation, respectively, to simulate the sensation of actual stimulation.

sham stimulation

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meeting the diagnostic criteria for Parkinson's disease in China (2016 version), diagnosed as PD by two neurologists;
  • Hoehn-Yahr stage 1.5-4;
  • Age \> 50 years old;
  • No signs of moderate to severe depression: Beck Depression Inventory-II (BDI-II) score \< 20;
  • No signs of dementia: Mini-Mental State Examination (MMSE) score \> 21;
  • No change in medication regimen in the four weeks prior to enrollment;
  • Right-handed.

You may not qualify if:

  • History of other neuropsychiatric disorders;
  • History of alcohol or drug abuse;
  • Previous history of TMS or traditional TES treatment;
  • Presence of non-MRI compatible metal implants in the body, such as deep brain stimulation devices, pacemakers or stents.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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
SPONSOR INVESTIGATOR
PI Title
Vice President of Anhui Medical University

Study Record Dates

First Submitted

April 9, 2025

First Posted

April 17, 2025

Study Start

September 1, 2024

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

April 17, 2025

Record last verified: 2025-04

Locations

CN(1)