The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorThe First Affiliated Hospital of Anhui Medical University

About this trial

This study aimed to observe the clinical efficacy and safety of single-target transcranial temporal stimulation (tTIS) intervention in Parkinson's disease (PD) patients and explore the neurophysiological mechanism of TIS intervention. The study was designed as a three-arm (A: GPi group, B: STN group, C: Sham group), randomized, double-blind, parallel-controlled trial. PD patients in the drug-off state (≥12 hours after drug withdrawal) were randomly assigned to receive either tTIS or sham stimulation targeting GPi/STN, with each stimulation lasting 30 minutes. Clinical symptom assessments were conducted before and after the intervention, and safety was monitored by researchers throughout the process.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Temporal Interference Stimulation

    Other intervention

    Temporal Interference Stimulation

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: GPi groupExperimental treatment 1 intervention
Group B: STN groupExperimental treatment 1 intervention
Group C: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Baseline,Immediately after a single stimulation

Secondary outcomes

1

Hoehn-Yahr Stage Scale

Time frame
Baseline,Immediately after a single stimulation
2

3-Meter Timed Up and Go Test

Time frame
Baseline,Immediately after a single stimulation
3

10-meter walking test

Time frame
Baseline,Immediately after a single stimulation
4

Upper and lower limb alternation

Time frame
Baseline,Immediately after a single stimulation

Other outcomes

Sponsors and contacts

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