NeuroprotectionNCT05445505
Neuroprotective Effects of iTBS in PD
A study testing intermittent theta burst stimulation in people with Neuroprotection and Parkinson Disease, run by Ruijin Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Neuroprotection, Parkinson Disease, Intermittent Theta Burst Stimulation
- What is being tested?
- intermittent theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Jun Liu, Professor, 64370045 ext. +86-021, jly0520@hotmail.com
About this study
Official title: 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.
- Being tested
- intermittent theta burst stimulation, sham iTBS
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulationDevice
Also called iTBS
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.
sham iTBSDevice
The pseudo-stimulation device looks and sounds the same as the iTBS device
| Study group | Role | What they receive |
|---|---|---|
| Early-start single iTBS group | Active comparator | The intensive period: 2 weeks The maintenance period: 12 weeks Receives: Device: intermittent theta burst stimulation |
| Early-start double iTBS group | Active comparator | The intensive period: 2 weeks The maintenance period: 12 weeks Receives: Device: intermittent theta burst stimulation |
| Delayed-start single iTBS group | Sham comparator | The intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks Receives: Device: intermittent theta burst stimulation; Device: sham iTBS |
| Delayed-start double iTBS group | Sham comparator | The intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks Receives: Device: intermittent theta burst stimulation; Device: sham iTBS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 28 weeks
Secondary outcomes (10)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 28 weeks
Group differences of adverse event
Compare the adverse event in four intervention groups.
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2022
- Study start1 Aug 2022
- Primary completion30 Jun 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeuroprotectionStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Liu, Professor, Study chair, Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05445505
- Sponsor's protocol ID
- 2022043
- Status last verified
- May 2022
- First submitted
- 23 Jun 2022
- Last updated
- 9 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data (IPD) was available to other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuroprotective Effects of Intermittent Theta Burst Stimulation in Parkinson's Disease: a Delayed-start Randomized Double-blind Sham Controlled Study
- ClinicalTrials.gov ID
- NCT05445505
- Acronym / sponsor ID
- 2022043
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 6 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early-start single iTBS group | Active comparator | Device: intermittent theta burst stimulationThe intensive period: 2 weeks The maintenance period: 12 weeks |
| Early-start double iTBS group | Active comparator | Device: intermittent theta burst stimulationThe intensive period: 2 weeks The maintenance period: 12 weeks |
| Delayed-start single iTBS group | Sham comparator | Device: intermittent theta burst stimulation, Device: sham iTBSThe intensive period: sham/iTBS, 2 weeks The maintenance period: daily sham/iTBS, 12 weeks |
| Delayed-start double iTBS group | Sham comparator | Device: intermittent theta burst stimulation, Device: sham iTBSThe intensive period: sham/iTBS, 2 weeks The maintenance period: twice daily sham/iTBS, 12 weeks |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent theta burst stimulationAlso: iTBSiTBS is a new form of excitatory rTMS treatment that is less time-consuming and more effective than traditional rTMS in a single treatment session. | Device | Delayed-start double iTBS group, Delayed-start single iTBS group, Early-start double iTBS group, Early-start single iTBS group |
| sham iTBSThe pseudo-stimulation device looks and sounds the same as the iTBS device | Device | Delayed-start double iTBS group, Delayed-start single iTBS group |
Primary outcome
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes
Time frame: 28 weeks
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).
10 secondary outcomes
Group differences of Hoehn-Yahr stage
Time frame: 28 weeks
Group differences of Berg Balance Scale (BBS) changes
Time frame: 28 weeks
Group differences of Hamilton depression scale-17 (HAMD-17) changes
Time frame: 28 weeks
Group differences of Hamilton Anxiety Scale (HAMA) changes
Time frame: 28 weeks
Group differences of Mini-mental State Examination (MMSE) changes
Time frame: 28 weeks
Group differences of Montreal Cognitive Assessment (MoCA) changes
Time frame: 28 weeks
Group differences of 39-item Parkinson's Disease Questionnaire (PDQ-39) changes
Time frame: 28 weeks
Group differences of 16-item Sniffin' Sticks test (SS-16) changes
Time frame: 28 weeks
Group differences of Wexner changes
Time frame: 28 weeks
Group differences of adverse event
Time frame: 28 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2023.
- Individual participant dataSharing planned: No. No individual participant data (IPD) was available to other researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun Liu, Professor study chair
Department of Neurology, Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent theta burst stimulation in people with Neuroprotection and Parkinson Disease, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jun Liu, Professor (64370045 ext. +86-021, jly0520@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group differences of part 3 of Unified Parkinson Disease Rating Scale (UPDRS) changes (time frame: 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2023.