Transcranial Magnetic StimulationNCT06365190
Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
A study testing transcranial magnetic stimulation and Pharmacotherapy（antiparkinsonian drugs） in people with Transcranial Magnetic Stimulation and Parkinson's Disease, run by Anhui Medical University at 1 site in China.
Trial summary
Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Transcranial Magnetic Stimulation, Parkinson's Disease
- What is being tested?
- transcranial magnetic stimulation and Pharmacotherapy（antiparkinsonian drugs）
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteChina
- Study dates
- 6 Apr 2020to 31 Jul 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the Chinese diagnostic criteria for Parkinson's disease (2016 version);
- Age ≥ 40 years old;
- Stable use of medication for at least 2 weeks;
- MMSE score ≧ 24 points;
- Those who can cooperate to complete the experiment; (6) Those who have not received rTMS treatment in the past.
Who cannot join
- History or clinical symptoms of other serious mental illnesses (such as major depression, psychosis, or obsessive-compulsive disorder);
- Severe organic brain defects on T1 or T2 images;
- History or unknown epilepsy Cause of loss of consciousness;
- Head injury, stroke or other neurological disease;
- Immovable metal objects on or around the head;
- History of drug abuse within the past 6 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Cognitive Neuropsychology Lab Anhui Medical University
Hefei, Anhui, 230022
About this study
Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.
Read the detailed description
This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease.
Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.
- Being tested
- transcranial magnetic stimulation, Pharmacotherapy（antiparkinsonian drugs）
- Keywords
- Transcranial Magnetic Stimulation, Parkinson's Disease
- 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 14 consecutive days. Each treatment day comprised three 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.
Pharmacotherapy（antiparkinsonian drugs）Drug
Anti-Parkinson's disease drugs include compound levodopa, dopamine receptor agonists, monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, etc. Take dopaminergic agents regularly, with follow-up every 8 weeks including medication guidance and symptom assessment
| Study group | Role | What they receive |
|---|---|---|
| cTBS group | Experimental | On the basis of drug treatment, a course of TBS treatment is performed every eight weeks. Receives: Other: transcranial magnetic stimulation |
| Drug group | Other | Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment Receives: Drug: Pharmacotherapy（antiparkinsonian drugs） |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's Disease Rating Scale III scores
This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
Measured: baseline; week 3; week 13;week 23;week 33
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; week 3; week 13;week 23;week 33
Levodopa equivalent dose
Different antiparkinsonian drugs converted to equivalent amounts of levodopa.
Measured: baseline; week 3; week 13;week 23;week 33
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2024
- Study start6 Apr 2020
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
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
- NCT06365190
- Sponsor's protocol ID
- AHMU-PD-rTMS
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 16 Apr 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 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease
- ClinicalTrials.gov ID
- NCT06365190
- Acronym / sponsor ID
- AHMU-PD-rTMS
- Keywords
- Transcranial Magnetic Stimulation, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Anhui Medical UniversityUniversity, hospital or other
- Study start
- 6 Apr 2020 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 15 Apr 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.
Previous studies have shown that repetitive transcranial magnetic stimulation(rTMS) can improve clinical symptoms of Parkinson's disease(PD). Continuous theta-burst stimulation(cTBS) is a novel rTMS protocol that produces physiological effects b acting on neurons in the brain, which can decrease the excitability of motor system. This study aims to explore the long-term effects of cTBS on improvement of movement symptoms in patients with PD.
Detailed description
This was a open-label clinical trial to assess the Effects of a Periodic Repetitive Transcranial Magenetic Stimulation in Parkinson Disease.
Participants were randomly assigned to the cTBS group and the control group on a 1:1 basis using age as a stratification factor. In the cTBS group, after baseline assessment, participants received cTBS treatment on the left supplementary motor area(SMA) for 14 days, and symptoms were assessed on the second day after treatment. Ten weeks after completion of assessment, a second cTBS session was performed, with all patients taking stable doses of antiparkinsonian medications. The control group only received drug intervention, and symptom assessment was conducted at weeks 13, 23 , 33 , and 43. To rule out the influence of medication on symptom assessment, all patients stopped taking medication for at least 12 hours before assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cTBS group | Experimental | Other: transcranial magnetic stimulationOn the basis of drug treatment, a course of TBS treatment is performed every eight weeks. |
| Drug group | Other | Drug: Pharmacotherapy（antiparkinsonian drugs）Take antiparkinsonian medications regularly, with follow-up every 8 weeks including medication guidance and symptom assessment |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Meet the Chinese diagnostic criteria for Parkinson's disease (2016 version);
- Age ≥ 40 years old;
- Stable use of medication for at least 2 weeks;
- MMSE score ≧ 24 points;
- Those who can cooperate to complete the experiment; (6) Those who have not received rTMS treatment in the past.
Key exclusion criteria (6 listed)
- History or clinical symptoms of other serious mental illnesses (such as major depression, psychosis, or obsessive-compulsive disorder);
- Severe organic brain defects on T1 or T2 images;
- History or unknown epilepsy Cause of loss of consciousness;
- Head injury, stroke or other neurological disease;
- Immovable metal objects on or around the head;
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 14 consecutive days. Each treatment day comprised three 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 | cTBS group |
| Pharmacotherapy（antiparkinsonian drugs）Anti-Parkinson's disease drugs include compound levodopa, dopamine receptor agonists, monoamine oxidase type B inhibitors, catechol-O-methyl transferase inhibitors, etc. Take dopaminergic agents regularly, with follow-up every 8 weeks including medication guidance and symptom assessment | Drug | Drug group |
Primary outcome
Unified Parkinson's Disease Rating Scale III scores
Time frame: baseline; week 3; week 13;week 23;week 33
This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
2 secondary outcomes
Hoehn-Yahr(H-Y) stage
Time frame: baseline; week 3; week 13;week 23;week 33
Levodopa equivalent dose
Time frame: baseline; week 3; week 13;week 23;week 33
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Pharmacotherapy（antiparkinsonian drugs） in people with Transcranial Magnetic Stimulation and Parkinson's 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 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: status not confirmed, as of the sponsor's last update on 16 Apr 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?
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?
Unified Parkinson's Disease Rating Scale III scores (time frame: baseline; week 3; week 13;week 23;week 33). 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 16 Apr 2024.