Neuroprotective Effects of iTBS in PD

Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study

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 Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Neuroprotection; Intermittent Theta Burst Stimulation
• Intervention / Treatment: Device: intermittent theta burst stimulation; Device: sham iTBS

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun Liu, Professor; Phone Number: +86-021 64370045; Email: jly0520@hotmail.com

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
      • Contact: Jun Liu, Professor; Phone Number: +86-021 64370045; Email: jly0520@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Early-start single iTBS group; The intensive period: 2 weeks The maintenance period: 12 weeks	Device: intermittent theta burst stimulation; 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.; Other Names: iTBS
Active Comparator: Early-start double iTBS group; The intensive period: 2 weeks The maintenance period: 12 weeks	Device: intermittent theta burst stimulation; 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.; Other Names: iTBS
Sham Comparator: Delayed-start single iTBS group; The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks	Device: intermittent theta burst stimulation; 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.; Other Names: iTBS; Device: sham iTBS; The pseudo-stimulation device looks and sounds the same as the iTBS device
Sham Comparator: Delayed-start double iTBS group; The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks	Device: intermittent theta burst stimulation; 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.; Other Names: iTBS; Device: sham iTBS; The pseudo-stimulation device looks and sounds the same as the iTBS device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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).	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).	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).	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).	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).	28 weeks
Group differences of adverse event	Compare the adverse event in four intervention groups.	28 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Chair: Jun Liu, Professor, Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 30, 2022
• First Posted (Actual): July 6, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2022043

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data (IPD) was available to other researchers.

Drug and device information, study documents

• 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