Parkinson's Disease
Conditions
Keywords
TMS, Parkinson's disease
Brief summary
The goal of this clinical trial is to compare the efficacy of targeting the newly discovered SCAN versus traditional effector-specific networks in M1 using multimodal imaging and rTMS in patients with Parkinson's disease. The main question it aims to answer is: Is rTMS targeting the SCAN more effective than rTMS targeting effector networks?
Detailed description
Parkinson's disease (PD) is a neurodegenerative disorder commonly affecting middle-aged and elderly individuals. Besides conventional treatments such as medication (e.g., levodopa) and surgery (e.g., deep brain stimulation), non-invasive neuromodulation techniques, such as transcranial magnetic stimulation (TMS), have been widely used as a safe and well-tolerated non-pharmacological adjunct therapy for PD patients. However, the limited efficacy of TMS may be attributed to an incomplete understanding of PD-related cortical circuits and imprecise targeting. Historically, the primary motor cortex (M1) has been selected as the repetitive TMS (rTMS) target for PD treatment. In 2022, Gordon et al. discovered a new network within the M1 that differs from effector-specific networks responsible for executing movements of specific body parts, such as those for the foot, hand, and face. This newly identified network, named the somato-cognitive action network (SCAN), is located in inter-effector regions and is responsible for motor planning, control, and coordination. Damage to this network correlates with key PD symptoms, making SCAN a promising new target for PD intervention. This study aims to compare the efficacy of targeting the newly discovered SCAN versus traditional effector-specific networks in M1 using multimodal imaging and Intermittent theta burst stimulation (iTBS), a rapid form of rTMS. The objective is to provide new clinical evidence for non-invasive neuromodulation in Parkinson's disease.
Interventions
DEVICEIntermittent theta burst stimulation (iTBS)
iTBS: 90% RMT, 50Hz intraburst frequency, 3 pulses per burst, 5Hz interburst frequency, 2 seconds on/8 seconds off, totaling 1800 pulses over approximately 10 minutes. Each day includes 4 iTBS sessions (1800 pulses per session) with 50-minute intervals, totaling 7200 pulses per day for 14 consecutive days (100800 pulses total).
Sponsors
Henan Provincial People's Hospital
Changping Laboratory
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of primary PD per the MDS Clinical Diagnostic Criteria (2015) or the Chinese Parkinson's Disease Diagnostic Criteria (2016). * Age 18-75. * Stable use of anti-PD medication for at least two months prior to enrollment. * Normal cognitive function (MMSE \> 24). * Understanding of the study and signing of informed consent.
Exclusion criteria
* Diagnosed with other neurological diseases, such as stroke, brain tumor, traumatic brain injury, motor neuron disease, Alzheimer's disease, multiple sclerosis, etc. * Implanted medical devices incompatible with MRI, such as deep brain stimulators, pacemakers, cochlear implants, or vagus nerve stimulators. * Conditions contraindicated for MRI, such as claustrophobia, tattoos, or magnetic metal implants. * Personal or family history of epilepsy. * Prior neuromodulation treatments (e.g., TMS, transcranial electrical stimulation, transcranial ultrasound stimulation) within the last three months. * Other health abnormalities that the investigator deems unsuitable for study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS-III | Baseline, 7 days, 14 days | The primary outcome is the difference in MDS-UPDRS-III scores at the on state at day 7 and day 14 after iTBS intervention. |
Countries
China
Outcome results
None listed