Back to resultsNeuroprotective Effects of iTBS in PD
Primary Purpose
Neuroprotection, Parkinson Disease, Intermittent Theta Burst Stimulation
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intermittent theta burst stimulation
sham iTBS
Sponsored by
About this trial
This is an interventional treatment trial for Neuroprotection
Eligibility Criteria
Inclusion Criteria:
- Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).
- aged >20 years and <80 years, regardless of gender.
- 2 ≤ Hoehn-Yahr stage≤ 4.
- Maintain medication stability during the study period.
- Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.
Exclusion Criteria:
- Patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery.
- Patients with significant cognitive impairment (MMSE < 24) or inability to complete questionnaires independently.
- Prior treatment with TMS, DBS or SCS.
- Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
- Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
- Are currently taking other investigational drugs.
- Any other condition that the investigator deems unsuitable for participation in this study.
Sites / Locations
- Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Sham Comparator
Sham Comparator
Arm Label
Early-start single iTBS group
Early-start double iTBS group
Delayed-start single iTBS group
Delayed-start double iTBS group
Arm Description
The intensive period: 2 weeks The maintenance period: 12 weeks
The intensive period: 2 weeks The maintenance period: 12 weeks
The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks
The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks
Outcomes
Primary Outcome Measures
Group 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).
Secondary Outcome Measures
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).
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).
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).
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).
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).
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).
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).
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).
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).
Group differences of adverse event
Compare the adverse event in four intervention groups.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05445505
Brief Title
Neuroprotective Effects of iTBS in PD
Official Title
Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ruijin Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuroprotection, Parkinson Disease, Intermittent Theta Burst Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early-start single iTBS group
Arm Type
Active Comparator
Arm Description
The intensive period: 2 weeks The maintenance period: 12 weeks
Arm Title
Early-start double iTBS group
Arm Type
Active Comparator
Arm Description
The intensive period: 2 weeks The maintenance period: 12 weeks
Arm Title
Delayed-start single iTBS group
Arm Type
Sham Comparator
Arm Description
The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks
Arm Title
Delayed-start double iTBS group
Arm Type
Sham Comparator
Arm Description
The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks
Intervention Type
Device
Intervention Name(s)
intermittent theta burst stimulation
Other Intervention Name(s)
iTBS
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
sham iTBS
Intervention Description
The pseudo-stimulation device looks and sounds the same as the iTBS device
Primary Outcome Measure Information:
Title
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
Description
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
Secondary Outcome Measure Information:
Title
Group differences of Hoehn-Yahr stage
Description
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
Title
Group differences of Berg Balance Scale (BBS) changes
Description
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
Title
Group differences of Hamilton depression scale-17 (HAMD-17) changes
Description
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
Title
Group differences of Hamilton Anxiety Scale (HAMA) changes
Description
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
Title
Group differences of Mini-mental State Examination (MMSE) changes
Description
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
Title
Group differences of Montreal Cognitive Assessment (MoCA) changes
Description
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
Title
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
Description
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
Title
Group differences of 16-item Sniffin' Sticks test (SS-16) changes
Description
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
Title
Group differences of Wexner changes
Description
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
Title
Group differences of adverse event
Description
Compare the adverse event in four intervention groups.
Time Frame
28 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Meet the revised clinical diagnostic criteria for Parkinson's disease of the Movement Disorder Society (MDS) International (2015 version).
aged >20 years and <80 years, regardless of gender.
2 ≤ Hoehn-Yahr stage≤ 4.
Maintain medication stability during the study period.
Good compliance, written informed consent, and consent for long-term interventional treatment with iTBS.
Exclusion Criteria:
Patients with severe neuropsychiatric disorders or previous history of severe neurological disorders (e.g., epilepsy, cerebrovascular accidents, etc.) or history of traumatic brain injury or brain surgery.
Patients with significant cognitive impairment (MMSE < 24) or inability to complete questionnaires independently.
Prior treatment with TMS, DBS or SCS.
Severe physical illness and any physical illness that can precipitate epilepsy or intracranial hypertension, including cardiovascular and respiratory disease.
Have human implantable materials such as intracranial stents, pacemakers, coronary stents, cochlear implants, etc.
Are currently taking other investigational drugs.
Any other condition that the investigator deems unsuitable for participation in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Liu, Professor
Phone
64370045
Ext
+86-021
Email
jly0520@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Liu, Professor
Organizational Affiliation
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Liu, Professor
Phone
64370045
Ext
+86-021
Email
jly0520@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual participant data (IPD) was available to other researchers.
Learn more about this trial
Neuroprotective Effects of iTBS in PD
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