Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06931483

The Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) Targeting the Right Globus Pallidus Internus (GPi) for Motor Symptoms in Patients With PD

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Conditions

Temporal Interference Stimulation Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Motor Symptoms Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Synucleinopathies the Right Globus Pallidus Internus

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anhui Medical University

Hefei, Anhui, China

About this study

Each of patients received either 30-minute or sham tTIS of the right GPi. Before and immediately after the stimulation, participants completed the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS-III) in the "medication-on" state to assess the motor symptoms. MDS-UPDRS, HAMA and HAMD were assessed on intervention Day 1, Day 10 and 1-month follow-up and clinical efficacy was evaluated by comparing the scale scores before and after the intervention.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

Secondary outcomes

  1. emotional symptoms assessed by the HAMA

    Time frame: on intervention Day 1, Day 10 and 1-month follow-up

    The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.

  2. emotional symptoms assessed by the HAMD

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

    The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.

Sponsors and collaborators

Lead sponsor

Yanghua Tian

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.