Temporal Interference Stimulation (TIS), Parkinson's Disease
Conditions
Keywords
TIS, Parkinson, UPDRS
Brief summary
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.
Interventions
DEVICETIS
Temporal Interference Stimulation
Sponsors
Zhongnan Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult males or females aged 40 years or above; 2. Diagnosed with idiopathic Parkinson's disease according to the UK Brain Bank Criteria, with onset after 40 years of age; 3. Previous or current dopaminergic replacement therapy (e.g., levodopa) with good response; (4) Hoehn and Yahr (H&Y) stage 1.5-2.5; 4. Ability to walk independently without assistive devices for at least 5 minutes; 5. Absence of severe freezing of gait (FOG); 6. Disease duration ≥2 years since diagnosis, with stable clinical condition and ability to comply with study assessments and interventions; 7. Stable medication dosage for at least 4 weeks prior to the study; 8. Hoehn and Yahr (H&Y) stage 1.5-2.5; 9. Signed informed consent, with the participant or legal guardian capable of understanding and willing to participate in the study.
Exclusion criteria
1. Presence of other neurological disorders that may interfere with the study 2. Mild or greater cognitive impairment (MoCA score ≤23) 3. Orthopedic or other health conditions that may affect gait or balance 4. Contraindications to MRI scanning, such as claustrophobia 5. History of antipsychotic, antidepressant, or other medications that may affect dopamine levels 6. Other significant psychiatric history 7. Contraindications including history of epilepsy, traumatic brain injury, or implanted metal devices in the brain or heart (e.g., stimulators, pacemakers) 8. History of electroconvulsive therapy 9. Concurrent participation in other gait- or balance-related intervention training 10. Physician-diagnosed cardiovascular risk factors for exercise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| UPDRS-3 | From enrollment through the 3-month follow-up | 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. |
Outcome results
None listed