Parkinsonian Syndromes, Parkinson's Disease
Conditions
Keywords
Parkinson's Disease and Parkinsonian Syndromes, Temporal Interference Noninvasive Deep Brain Stimulation
Brief summary
This study aims to explore the therapeutic effects of noninvasive deep brain electrical stimulation using temporal interference principles (Temporal Interference Stimulation, TIS) on both motor and non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes, and to investigate strategies for optimal stimulation target selection. A prospective, single-center, double-blind, randomized, crossover design will be implemented. Participants will be recruited from outpatient and inpatient departments of Ruijin Hospital, Shanghai Jiao Tong University School of Medicine. The primary hypothesis is that TIS will significantly improve motor symptoms in patients with Parkinson's disease and Parkinsonian syndromes. The primary outcome measure will be the change in the MDS-UPDRS Part III score from baseline to post-stimulation. This study is expected to provide direct evidence supporting the clinical application and target selection strategies of noninvasive deep brain stimulation for the treatment of Parkinson's disease and Parkinsonian syndromes.
Interventions
DEVICEAB Temporal Interference Stimulation
Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with AB sequence (Active → Sham). Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz; Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz.
DEVICEBA Temporal Interference Stimulation
Participants with PD or PDS receive TIS. Each session lasts 30 minutes for 3 consecutive days. The study uses a crossover design with BA sequence (Sham → Active). Sham stimulation: current 1.5-4 mA, carrier frequency 2000 Hz, frequency offset 0 Hz. Active stimulation: current 1.5-4 mA (patient's maximum tolerated), carrier frequency 2000 Hz, frequency offset 130 Hz;
Sponsors
Ruijin Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 40 to 80 years, diagnosed with idiopathic Parkinson's disease or Parkinsonian syndromes according to the Movement Disorder Society (MDS) diagnostic criteria. 2. Receiving stable doses of levodopa or other dopaminergic medications for at least 4 weeks prior to enrollment, with a documented response to levodopa; medication regimen must remain unchanged during the study. 3. Hoehn and Yahr (H\&Y) stage ≤ 3 in the "ON" medication state. 4. Normal cognitive function, defined as a Mini-Mental State Examination (MMSE) score ≥ 24. 5. Able to maintain and cooperate with Parkinson's disease symptom diaries. 6. Signed written informed consent.
Exclusion criteria
1. Presence of other neurological or psychiatric disorders that may interfere with study participation or outcomes. 2. Previous treatment with deep brain stimulation (DBS) or other invasive brain stimulation therapies. 3. Orthopedic or other medical conditions that could affect gait or balance. 4. Contraindications to MRI, such as claustrophobia or other factors making MRI unsuitable. 5. History of taking antipsychotic, antidepressant, or other medications that may affect dopamine levels. 6. Contraindications to electrical stimulation, such as implanted cardiac pacemakers or a history of epilepsy. 7. History of electroconvulsive therapy (ECT). 8. Severe comorbidities, including cardiovascular disease, respiratory disease, or hepatic/renal dysfunction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of temporal interference stimulation (TIS) on motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes | Baseline, 3 days after sham stimulation, and 3 days after active stimulation. | The MDS-UPDRS Part III is a rater-administered motor examination used to evaluate the severity of motor impairment in patients with idiopathic Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 132, with lower scores indicating less severe motor symptoms. Changes from baseline after real or sham stimulation will be analyzed and compared between groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary motor outcome | Baseline, 3 days after sham stimulation, and 3 days after active stimulation. | The UMSARS is a rater-administered scale used to assess disease severity in patients with Parkinsonian syndromes, particularly multiple system atrophy. The total score ranges from 0 to 104, with a higher score indicating greater disease severity. The change in UMSARS score from baseline to after stimulation will be compared between the real and sham stimulation groups. |
| Efficacy of TIS on non-motor symptoms in patients with idiopathic Parkinson's disease and Parkinsonian syndromes | Baseline, 3 days after sham stimulation, and 3 days after active stimulation. | The Hamilton Anxiety Rating Scale-14（HAMA-14）is a rater-administered scale used to assess the severity of anxiety symptoms. The total score ranges from 0 to 56, with a higher score indicating more severe anxiety. The change in HAMA-14 score from baseline to after stimulation will be compared between the real and sham stimulation groups. |
| Efficacy of TIS on quality of life in patients with idiopathic Parkinson's disease and Parkinsonian syndromes | Baseline, 3 days after sham stimulation, and 3 days after active stimulation. | The Parkinson's Disease Questionnaire-39 Summary Index（PDQ-39 SI）is a patient-reported scale used to assess health-related quality of life in patients with Parkinson's disease and Parkinsonian syndromes. The total score ranges from 0 to 100, with a higher score indicating poorer quality of life. The change in PDQ-39 SI score from baseline to after stimulation will be compared between the real and sham stimulation groups. |
| Potential mechanisms underlying the therapeutic effects of TIS in patients with idiopathic Parkinson's disease and Parkinsonian syndromes | Baseline, 3 days after sham stimulation, and 3 days after active stimulation. | Changes in resting-state EEG β-band oscillation power before and after stimulation |
| Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) | From baseline through study completion (up to 3 weeks) | The number and severity of all AEs and SAEs will be collected and monitored throughout the study to evaluate the safety and tolerability of the intervention. |
Countries
China
Outcome results
None listed