Study on the Efficacy of Temporal Interference Stimulation (TIS) for Parkinson's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorZhongnan Hospital
About this trial
The primary objective of this clinical study is to evaluate the therapeutic efficacy of Temporal Interference Stimulation (TIS), a non-invasive deep brain stimulation technique, in patients with Parkinson's disease, and to further investigate its potential mechanisms of action. Although TIS offers lower stimulation intensity and precision compared to conventional Deep Brain Stimulation (DBS), it possesses the distinct advantage of being non-invasive. This study utilizes TIS to explore different stimulation targets analogous to those used in DBS for Parkinson's disease, thereby providing valuable insights for subsequent DBS surgical interventions. The findings will contribute preliminary exploratory evidence regarding the application of non-invasive deep brain stimulation technology in the treatment of Parkinson's disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult males or females aged 40 years or above;
Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age;
Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H&Y) stage 1.5-2.5;
Ability to walk independently without assistive devices for at least 5 minutes;
Disqualifiers
Presence of other neurological disorders that may interfere with the study
Mild or greater cognitive impairment (MoCA score ≤23)
Orthopedic or other health conditions that may affect gait or balance
Contraindications to MRI scanning, such as claustrophobia
Trial design
Design model
Single group
Treatments tested in this trial
TIS
DeviceTemporal Interference Stimulation
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: A:STNExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
UPDRS-3
Changes in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) scores from baseline to immediately after and 1 month after a single treatment session.
Time frame
From enrollment through the 3-month follow-upLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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