Intermittent theta burst stimulation (iTBS) is an emerging non-invasive neuron regulation technique, which is widely used in neuropsychiatry for a variety of diseases and is widely accepted by patients due to its non-invasive, operable and relatively precise localization. Combining the results of previous studies and our group's previous research, sixty qualified PD patients would be enrolled to conduct a prospective single-center randomized double-blind sham controlled clinical trial to verify the long-term curative effects of iTBS treatment protocol and explore the neuron-protection of iTBS on neuronal loss of PD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
iTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session.
The pseudo-stimulation device looks and sounds the same as the iTBS device
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGGroup differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
Compare the changes in UPDRS scores from baseline to post-iTBS in the four intervention groups (UPDRS part3: range 0\~72, higher score is related to a worse outcome).
Time frame: 28 weeks
Group differences of Hoehn-Yahr stage
Compare the changes in Hoehn-Yahr stage from baseline to post-iTBS in the four intervention groups (H-Y stage: range 0\~5, higher score is related to a worse outcome).
Time frame: 28 weeks
Group differences of Berg Balance Scale (BBS) changes
Compare the changes in BBS scores from baseline to post-iTBS in the four intervention groups (BBS: range 0\~56, higher score is related to a better outcome).
Time frame: 28 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes
Compare the changes in HAMD-17 scores from baseline to post-iTBS in the four intervention groups (HAMD-17: range 0\~38, higher score is related to a worse outcome).
Time frame: 28 weeks
Group differences of Hamilton Anxiety Scale (HAMA) changes
Compare the changes in HAMA scores from baseline to post-iTBS in the four intervention groups (HAMA: range 0\~64, higher score is related to a worse outcome).
Time frame: 28 weeks
Group differences of Mini-mental State Examination (MMSE) changes
Compare the changes in MMSE scores from baseline to post-iTBS in the four intervention groups (MMSE: range 0\~30, higher score is related to a better outcome).
Time frame: 28 weeks
Group differences of Montreal Cognitive Assessment (MoCA) changes
Compare the changes in MoCA scores from baseline to post-iTBS in the four intervention groups (MoCA: range 0\~30, higher score is related to a better outcome).
Time frame: 28 weeks
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
Compare the changes in PDQ-39 scores from baseline to post-iTBS in the four intervention groups (PDQ-39: range 0\~156, higher score is related to a worse outcome).
Time frame: 28 weeks
Group differences of 16-item Sniffin' Sticks test (SS-16) changes
Compare the changes in SS-16 scores from baseline to post-iTBS in the four intervention groups (SS-16: range 0\~16, higher score is related to a better outcome).
Time frame: 28 weeks
Group differences of Wexner changes
Compare the changes in Wexner scores from baseline to post-iTBS in the four intervention groups (Wexner: range 0\~30, higher score is related to a worse outcome).
Time frame: 28 weeks
Group differences of adverse event
Compare the adverse event in four intervention groups.
Time frame: 28 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.