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Clinical Efficacy of Intermittent Theta Burst Transcranial Magnetic Stimulation With Different Modes on Parkinson's Disease
Condition(s) studied
ParkinsonismTranscranial Magnetic StimilationIntermittent Theta Burst StimulationPrimary Motor CortexElectroencephalographyNeuromodulation
Investigational drug(s) / intervention(s)
High-dose iTBS treatment groupLow-dose iTBS treatment groupSham stimulation group
High-dose iTBS treatment group: The stimulation intensity is 80% of the resting motor threshold (RMT), with an intra-burst frequency of 50 Hz and an inter-burst frequency of 5 Hz. Each train lasts 2 seconds, followed by an 8-second inter-train interval, delivering 1,800 pulses per session. The session is repeated after a 30-minute interval, with a total of 5 sessions per day (amounting to 9,000 pulses daily). Stimulation is administered for 5 consecutive days, resulting in a total of 45,000 pulses.
Low-dose iTBS treatment group: The stimulation intensity is 80% of the resting motor threshold (RMT), with an intra-burst frequency of 50 Hz and an inter-burst frequency of 5 Hz. Each train lasts 2 seconds, followed by an 8-second inter-train interval, delivering 1,800 pulses per session. Stimulation is administered once daily (1,800 pulses per day) for 5 consecutive days, resulting in a total of 9,000 pulses.
Sham stimulation group: The intervention procedure is identical to that of active stimulation, with the sole difference being the use of a specific sham coil. This sham coil has the same appearance as the active coil but is specially modified to produce no magnetic field, generating only vibration and sound.
Study summary
TMS regulates cortical excitability through electromagnetic induction, with low-frequency stimulation suppressing and high-frequency stimulation enhancing excitability. Building on theta-gamma coupling, iTBS induces broader improvements in functional brain connectivity within a shorter stimulation period, particularly by significantly reducing abnormal variability in the prefrontal and parietal regions, demonstrating superior neuromodulatory efficiency and network remodeling capacity. This study aims to compare the symptomatic effects of different iTBS protocols on Parkinson's disease, optimize stimulation parameters, and evaluate safety, while also analyzing the time-dependent trends of therapeutic efficacy through 1- and 3-month follow-ups.
Eligibility
Inclusion Criteria
* Aged 40-80 years; ② Diagnosis of idiopathic Parkinson's disease meeting the MDS Clinical Diagnostic Criteria for Parkinson's disease (2015 edition), with a disease duration of at least 3 years and Hoehn \& Yahr stage \< 4;
* Stable use of anti-parkinsonian medication for 2 weeks prior to the study and throughout the entire study period, with no dosage adjustments; ④ Concurrently meeting the diagnostic criteria for Parkinson's disease-related pain, with a frequency of at least 3 times per week and duration of at least 3 months; Numerical Rating Scale (NRS) score ≥ 3; ⑤ Passing the TMS Safety Screening Questionnaire (TSSQ);
* Passing the MRI Safety Screening Questionnaire (MSSQ); Exclusion Criteria
* Patients with other diseases that may affect peripheral nerve sensation, including but not limited to diabetes, herpes infection, stroke, or spinal cord disorders;
* Patients with comorbid severe depression or psychiatric disorders;
* Presence of severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score ≤ 9;
* Patients with concurrent intracranial organic lesions or a history of traumatic brain injury; ⑤ Patients with severe organic diseases involving the heart, liver, kidneys, or other vital organs; ⑥ Patients unable to undergo cranial MRI examination or TMS treatment due to claustrophobia, presence of implanted devices such as pacemakers, history of epilepsy, or other contraindications.
* Providing written informed consent.
Primary outcome measure(s)
- Assessment with the KPPS — at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment
King's PD Pain Scale (KPPS) includes 14 items rating the severity and frequency of pain, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a subscore of 0 to 12, with a total possible score range from 0 to 168. Higher scores indicate greater symptom severities and more serious influence.
- Assessment with the MKPPS — at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment
Modified King's PD Pain Scale (MKPPS)，the modified version which is more suitable for Chinese people, combined with Ford's pain subtypes basing on the original. It covers five main domains, including 16 items, each item scored by severity (0-3) multiplied by frequency (0-4), resulting in a total possible score range from 0 to 192. Higher scores indicate greater symptom severities and more serious influence.
- Change in Pain Intensity Scores (VAS) — at baseline, on day 1 after treatment, and at 1 month and 3 months after treatment
VAS, a 0-10 numeric rating scale with 0= no pain and 10=maximal pain. Higher scores indicate greater symptom severities and more serious influence.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| The Second Affiliated Hospital of Soochow University |
Suzhou |
Jiangsu |
|
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