The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Temporal Interference Stimulation.
- Who it may be relevant to
- Registry conditions: Parkinson s Disease. Basic parameters: from 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy and Safety of Temporal Interference Stimulation on Motor Symptoms of Parkinson's Disease: A Three-arm, Randomized, Double-blind, Parallel-controlled Study
Overview
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.
Interventions
- Other Temporal Interference Stimulation
Temporal Interference Stimulation
Primary outcome measures
- The part III of MDS-Unified Parkinson's Disease Rating Scale [Time frame: Baseline，Immediately after a single stimulation]
Secondary outcome measures (7)
- Hoehn-Yahr Stage Scale [Time frame: Baseline，Immediately after a single stimulation]
- 3-Meter Timed Up and Go Test [Time frame: Baseline，Immediately after a single stimulation]
- 10-meter walking test [Time frame: Baseline，Immediately after a single stimulation]
- Upper and lower limb alternation [Time frame: Baseline，Immediately after a single stimulation]
- Clinical Global Impression [Time frame: Baseline，Immediately after a single stimulation]
- Resting-state electroencephalogram（rsEEG） [Time frame: Baseline，Immediately after a single stimulation]
- Transcranial Magnetic Stimulation-Electroencephalography（TMS-EEG） [Time frame: Baseline，Immediately after a single stimulation]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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;
- Other situations that the researchers consider unsuitable for inclusion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Anhui Medical University — Hefei
Identifiers
NCT: NCT07572903 · AHMU-single TIS-PD