Transcranial Magnetic StimulationNCT06542991
An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation and Parkinson Disease, run by Anhui Medical University at 1 site in China.
Trial summary
To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Transcranial Magnetic Stimulation, Parkinson Disease, Supplementary Motor Area
- What is being tested?
- transcranial magnetic stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 31 Mar 2025
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years old
- Meet Movement Disorder Society standards;
- Have no history of drug adjustment within 4 weeks before and during treatment;
- The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
- MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.
Who cannot join
- Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
- Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
- Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
- There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
- The person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
- Diagnosed with a neuropsychiatric disorder other than PD
Show all 10Show fewer
- Have a history of drug abuse or drug use;
- Participants in any clinical trial within the previous 6 month;
- Pregnant/lactating women or subjects (including men) who have a birth plan within 6 months;
- Other conditions deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui
Kai Wang, Ph.D., +8655162923704, wangkai1964@126.com
Panpan Hu, M.D., 13515602285, hpppanda9@126.com
About this study
To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.
Read the detailed description
As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.
We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.
- Being tested
- transcranial magnetic stimulation
- Keywords
- Transcranial Magnetic Stimulation, Parkinson Disease, Supplementary motor area
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial magnetic stimulationOther
During treatment, the patient underwent cTBS targeting the left SMA for 7 consecutive days. Each treatment day comprised six rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period.
| Study group | Role | What they receive |
|---|---|---|
| rTMS group | Experimental | On the basis of drug treatment, a course of TBS treatment is performed for 7 days. Receives: Other: transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
The primary outcome was the change in MDS-UPDRS III from baseline to 9 weeks of follow-up. MDS-UPDRS III is a questionnaire used by uniformly trained professionals to evaluate motor symptoms in patients with Parkinson's disease[21]. The questionnaire consists of 18 items, which professionals need to score according to the patient's motor symptoms, on a scale of 0-4. Among them, items 3.3-3.8 and 3.15-3.17 can be divided into several sub-items according to the body parts. The results of MDS-UPDRS III are the total of 18 items.
Measured: baseline; day 8; week 5;week 9;
Secondary outcomes (2)
Hoehn-Yahr(H-Y) stage
It ranges from 1 to 5, and is evaluated based on the range of symptoms involved and whether balance is impaired in PD patients. The higher the score, the more severe the severity.
Measured: baseline; day 8; week 5;week 9;
The timed up and go test
TUG measures in seconds how long it takes the subject to rise from the chair, walk 3 meters, turn around, walk back to the chair, and sit down. The test is often used to assess walking and balance in older adults. This also applies to evaluating the severity of walking and balance symptoms in patients with Parkinson's disease.
Measured: baseline; day 8; week 5;week 9;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Magnetic StimulationStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, WANG KAI, Anhui Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542991
- Sponsor's protocol ID
- PD-OPEN
- Status last verified
- Aug 2024
- First submitted
- 3 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Study on the Clinical Efficacy of rTMS Intervention in PD
- ClinicalTrials.gov ID
- NCT06542991
- Acronym / sponsor ID
- PD-OPEN
- Keywords
- Transcranial Magnetic Stimulation, Parkinson Disease, Supplementary motor area
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 7 Aug 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.
To demonstrate that intervention targeting the supplementary motor area (SMA) using precise navigation positioning can effectively improve motor symptoms in patients with Parkinson's disease.
Detailed description
As an innovative non-invasive neuromodulation technology, repetitive transcranial magnetic stimulation (rTMS) has demonstrated efficacy in improving motor symptoms in patients with Parkinson's disease (PD). The supplementary motor area (SMA) has been identified as a brain region significantly associated with motor symptoms in PD patients. However, no large-sample clinical studies have yet established the clinical efficacy of rTMS, guided by neuroimaging navigation, targeting the SMA in patients with Parkinson's disease.
We describe a open-lable study designed to recruit 20 patients with idiopathic Parkinson's disease. Participants will be randomly assigned to receive either real stimulation or sham stimulation, with the left SMA undergoing 7 days of continuous theta burst stimulation (cTBS). The primary outcome measure is the change in the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III scores from baseline to post-treatment and follow-up. Secondary outcomes include changes in scores on other clinical symptom scales.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rTMS group | Experimental | Other: transcranial magnetic stimulationOn the basis of drug treatment, a course of TBS treatment is performed for 7 days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥40 years old
- Meet Movement Disorder Society standards;
- Have no history of drug adjustment within 4 weeks before and during treatment;
- The MDS-UPDRS Ⅲ score ≥8, and the Hoehn-Yahr rating is 1-4
- MMSE ≥24，able to cooperate with the completion of behavioral tests and transcranial magnetic stimulation therapy.
Key exclusion criteria (10 listed)
- Head MRI/CT ruled out focal brain injury or severe leukoencephalopathy (Fazekas grade 3);
- Various secondary parkinsonism syndromes (vascular parkinsonism, Parkinsonism combined with parkinsonism, drug parkinsonism, etc.);
- Severe craniocerebral trauma, received craniocerebral surgery or deep brain stimulation treatment;
- There are ferromagnetic implants in the body, such as cochlear implants, cardiac pacemakers, etc.
- The person or first-degree relatives have a history of epilepsy, unexplained loss of consciousness, or are taking anticonvulsant drugs to treat epileptic seizures;
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 |
|---|---|---|
| transcranial magnetic stimulationDuring treatment, the patient underwent cTBS targeting the left SMA for 7 consecutive days. Each treatment day comprised six rounds of cTBS, with a 15-minute interval between each. A single cTBS session involved trains of three pulses at 50 Hz, repeated every 200 ms (5 Hz), until reaching a total of 600 pulses, lasting 40s. Stimulation intensity remained at 80% of resting motor threshold. In total, patients received 25,200 pulses throughout the treatment period. | Other | rTMS group |
Primary outcome
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ
Time frame: baseline; day 8; week 5;week 9;
The primary outcome was the change in MDS-UPDRS III from baseline to 9 weeks of follow-up. MDS-UPDRS III is a questionnaire used by uniformly trained professionals to evaluate motor symptoms in patients with Parkinson's disease[21]. The questionnaire consists of 18 items, which professionals need to score according to the patient's motor symptoms, on a scale of 0-4. Among them, items 3.3-3.8 and 3.15-3.17 can be divided into several sub-items according to the body parts. The results of MDS-UPDRS III are the total of 18 items.
2 secondary outcomes
Hoehn-Yahr(H-Y) stage
Time frame: baseline; day 8; week 5;week 9;
The timed up and go test
Time frame: baseline; day 8; week 5;week 9;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial magnetic stimulation in people with Transcranial Magnetic Stimulation and Parkinson Disease, run by Anhui Medical University 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 10 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 7 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Wang, Ph.D. (055162923704, wangkai1964@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale Part Ⅲ (time frame: baseline; day 8; week 5;week 9;). 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 7 Aug 2024.