Parkinson's DiseaseNCT06734676
fMRI-guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease
A study testing Intermittent theta burst stimulation (iTBS) in people with Parkinson's Disease, run by Changping Laboratory at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Intermittent theta burst stimulation (iTBS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 29 May 2023to 15 May 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of Multi-Modal Imaging Technology in MRI-Guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease
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?
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Intermittent theta burst stimulation (iTBS)
- Keywords
- TMS, Parkinson's disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittent theta burst stimulation (iTBS)Device
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).
| Study group | Role | What they receive |
|---|---|---|
| SCAN | Experimental | 14-day iTBS on personalized SCAN localized by precision functional mapping Receives: Device: Intermittent theta burst stimulation (iTBS) |
| Effector | Active comparator | 14-day iTBS on personalized effector-specific network localized by precision functional mapping Receives: Device: Intermittent theta burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
MDS-UPDRS-III
The primary outcome is the difference in MDS-UPDRS-III scores at the "on" state at day 7 and day 14 after iTBS intervention.
Measured: Baseline, 7 days, 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start29 May 2023
- Primary completion28 Apr 2024
- Study completion15 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changping Laboratory
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Responsible party
- Sponsor
- Investigators
- Hesheng Liu, PhD, Study chair, Changping Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734676
- Sponsor's protocol ID
- PDHNTMS
- Status last verified
- May 2023
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified patient data will be available to researchers upon reasonable request by contacting the corresponding authors after the publication of relevant papers.
Publications
Gordon EM, Chauvin RJ, Van AN, Rajesh A, Nielsen A, Newbold DJ, Lynch CJ, Seider NA, Krimmel SR, Scheidter KM, Monk J, Miller RL, Metoki A, Montez DF, Zheng A, Elbau I, Madison T, Nishino T, Myers MJ, Kaplan S, Badke D'Andrea C, Demeter DV, Feigelis M, Ramirez JSB, Xu T, Barch DM, Smyser CD, Rogers CE, Zimmermann J, Botteron KN, Pruett JR, Willie JT, Brunner P, Shimony JS, Kay BP, Marek S, Norris SA, Gratton C, Sylvester CM, Power JD, Liston C, Greene DJ, Roland JL, Petersen SE, Raichle ME, Laumann TO, Fair DA, Dosenbach NUF. A somato-cognitive action network alternates with effector regions in motor cortex. Nature. 2023 May;617(7960):351-359. doi: 10.1038/s41586-023-05964-2. Epub 2023 Apr 19.
PubMed 37076628Latorre A, Rocchi L, Berardelli A, Bhatia KP, Rothwell JC. The use of transcranial magnetic stimulation as a treatment for movement disorders: A critical review. Mov Disord. 2019 Jun;34(6):769-782. doi: 10.1002/mds.27705. Epub 2019 Apr 29.
PubMed 31034682Zhang W, Deng B, Xie F, Zhou H, Guo JF, Jiang H, Sim A, Tang B, Wang Q. Efficacy of repetitive transcranial magnetic stimulation in Parkinson's disease: A systematic review and meta-analysis of randomised controlled trials. EClinicalMedicine. 2022 Jul 29;52:101589. doi: 10.1016/j.eclinm.2022.101589. eCollection 2022 Oct.
PubMed 35923424
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Multi-Modal Imaging Technology in MRI-Guided Transcranial Magnetic Stimulation Treatment for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06734676
- Acronym / sponsor ID
- PDHNTMS
- Conditions
- Parkinson's Disease
- Keywords
- TMS, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Changping LaboratoryUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital
- Study start
- 29 May 2023 (actual)
- Primary completion
- 28 Apr 2024 (actual)
- Study completion
- 15 May 2024 (actual)
- First posted
- 16 Dec 2024 (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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCAN | Experimental | Device: Intermittent theta burst stimulation (iTBS)14-day iTBS on personalized SCAN localized by precision functional mapping |
| Effector | Active comparator | Device: Intermittent theta burst stimulation (iTBS)14-day iTBS on personalized effector-specific network localized by precision functional mapping |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
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 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). | Device | Effector, SCAN |
Primary outcome
MDS-UPDRS-III
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Background: PubMed 37076628Gordon EM, Chauvin RJ, Van AN, Rajesh A, Nielsen A, Newbold DJ, Lynch CJ, Seider NA, Krimmel SR, Scheidter KM, Monk J, Miller RL, Metoki A, Montez DF, Zheng A, Elbau I, Madison T, Nishino T, Myers MJ, Kaplan S, Badke D'Andrea C, Demeter DV, Feigelis M, Ramirez JSB, Xu T, Barch DM, Smyser CD, Rogers CE, Zimmermann J, Botteron KN, Pruett JR, Willie JT, Brunner P, Shimony JS, Kay BP, Marek S, Norris SA, Gratton C, Sylvester CM, Power JD, Liston C, Greene DJ, Roland JL, Petersen SE, Raichle ME, Laumann TO, Fair DA, Dosenbach NUF. A somato-cognitive action network alternates with effector regions in motor cortex. Nature. 2023 May;617(7960):351-359. doi: 10.1038/s41586-023-05964-2. Epub 2023 Apr 19.
- Background: PubMed 31034682Latorre A, Rocchi L, Berardelli A, Bhatia KP, Rothwell JC. The use of transcranial magnetic stimulation as a treatment for movement disorders: A critical review. Mov Disord. 2019 Jun;34(6):769-782. doi: 10.1002/mds.27705. Epub 2019 Apr 29.
- Background: PubMed 35923424Zhang W, Deng B, Xie F, Zhou H, Guo JF, Jiang H, Sim A, Tang B, Wang Q. Efficacy of repetitive transcranial magnetic stimulation in Parkinson's disease: A systematic review and meta-analysis of randomised controlled trials. EClinicalMedicine. 2022 Jul 29;52:101589. doi: 10.1016/j.eclinm.2022.101589. eCollection 2022 Oct.
- Individual participant dataSharing planned: Yes. De-identified patient data will be available to researchers upon reasonable request by contacting the corresponding authors after the publication of relevant papers.
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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.
Hesheng Liu, PhD study chair
Changping Laboratory
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 (iTBS) in people with Parkinson's Disease, run by Changping Laboratory 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 6 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: finished, as of the sponsor's last update on 16 Dec 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MDS-UPDRS-III (time frame: Baseline, 7 days, 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06734676, which also lists 3 linked publications.
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 16 Dec 2024.