Parkinson's DiseaseNCT06009471
A Multicenter Clinical Study of rTMS for Parkinson's Disease
A study testing Routine treatment in Neurology and Routine treatment in Neurology and rTMS in people with Parkinson's Disease, run by Affiliated Hospital of Nantong University at 1 site in China.
Trial summary
Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Routine treatment in Neurology and Routine treatment in Neurology and rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to Aug 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hoehn-YAHR classification is between 1 and 2；
- Have a primary school education or above and can read the scale used in this study;
- MoCA score between 20 and 24, mild cognitive impairment ;
- Aged between 30 and 80, regardless of gender；
- Voluntarily participate and sign informed consent.
Who cannot join
- patients with cerebrovascular accident, craniocerebral injury and other diseases affecting muscle tension;
- patients with serious mental disorders and cognitive disorders who cannot cooperate with assessment;
- patients with severe liver, kidney, heart dysfunction and severe physical disorders;
- Implanted devices such as pacemakers are installed inside the body;
- drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;
- Have a history of epilepsy;
- Women during pregnancy and breastfeeding.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
rTMS
Nantong, Jiangsu, 226001
Aisong Guo, 15851300188, guoasg@ntu.edu.cn
About this study
Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.
Read the detailed description
According to the inclusion criteria, a total of 200 patients with Parkinson's disease were planned to be enrolled in each center, and randomly divided into control group (conventional treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4 weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks, respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were recorded.
- Conditions
- Parkinson's Disease
- Being tested
- Routine treatment in Neurology, Routine treatment in Neurology and rTMS
- Keywords
- Parkinson's disease, repetitive transcranial magnetic stimulation(rTMS), Unified Parkinson's Disease Rating Scale (UPDRS), Montreal Cognitive Assessment Scale (MoCA), activity of daily living(ADL), PD Sleep Scale (PDSS), King's Parkinson's Pain Assessment (KPPS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine treatment in NeurologyOther
Routine treatment in Neurology department, including drug treatment,etc.
Routine treatment in Neurology and rTMSDevice
Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | All participants were treated with routine treatment in Neurology. Receives: Other: Routine treatment in Neurology |
| Experimental group | Experimental | All participants were treated with routine treatment in Neurology and rTMS treatment.
rTMS parameters were set to stimulate the site: bilateral primary motor cortex; Stimulus frequency :5Hz; Pulse number: 1000 pulses per day, 500 on the left and 500 on the right; Stimulus intensity :90% resting threshold; Coil: 70mm round coil; Once a day, 30 minutes each time, 5 days a week for 4 weeks Receives: Device: Routine treatment in Neurology and rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Parkinson's disease rating Scale （UPDRS）
16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Montreal Cognitive Assessment Scale (MoCA)
Full score of 30 points,>=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of<10.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
King's Parkinson's Pain Assessment (KPPS)
Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
PD Sleep Scale (PDSS)
Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Activities of daily living Assessment - Barthel
The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Secondary outcomes (2)
Hamilton Depression Scale (HAMD)
Evaluate depressive status, including 14 5-level scoring items (0-4 points) and 10 3-level scoring items (0-2 points). Score<8, no depression; 8 to 35 points, may be mild or moderate depression 35 points, may be severe depression.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Hamilton Anxiety Scale (HAMA)
Include 14 projects. All items of HAMA adopt a 5-level scoring method of 0~4 points, and the criteria of each level are: (0) is Asymptomatic; (1) Light; (2) Moderate; (3) Heavy; (4) Extremely heavy. The total score of HAMA can better reflect the severity of anxiety symptoms. The total score can be used to evaluate the severity of anxiety symptoms and evaluate the effectiveness of various drugs and psychological interventions in patients with anxiety and depression disorders. According to the data provided by the collaborative group of the Chinese scale, if the total score exceeds 29 points, it may be severe anxiety; Above 21 points, there must be obvious anxiety; If the score exceeds 14, there must be anxiety; If the score exceeds 7, there may be anxiety; If the score is less than 7, there are no symptoms of anxiety. Generally speaking, the total score of HAMA is higher than 14 points, indicating clinically significant anxiety symptoms for the evaluated subject.
Measured: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start1 Jul 2023
- Primary completionAug 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Affiliated Hospital of Nantong UniversityThe 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
- Model description
- A total of 200 patients with Parkinson's disease were enrolled in each center and randomly divided into control group (routine treatment) and observation group (routine treatment +rTMS).
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital of Nantong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009471
- Sponsor's protocol ID
- LCYJ-B06
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2023
- Last updated
- 24 Aug 2023
- 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 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Clinical Study of rTMS for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06009471
- Acronym / sponsor ID
- LCYJ-B06
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's disease, repetitive transcranial magnetic stimulation(rTMS), Unified Parkinson's Disease Rating Scale (UPDRS), Montreal Cognitive Assessment Scale (MoCA), activity of daily living(ADL), PD Sleep Scale (PDSS), King's Parkinson's Pain Assessment (KPPS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Affiliated Hospital of Nantong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 24 Aug 2023 (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.
Through rTMS, motor dysfunction and non-motor dysfunction of PD patients can be improved, working and living ability and quality of life of patients can be improved, and social burden and family burden can be reduced.
Detailed description
According to the inclusion criteria, a total of 200 patients with Parkinson's disease were planned to be enrolled in each center, and randomly divided into control group (conventional treatment) and observation group (conventional treatment +rTMS) for a treatment cycle of 4 weeks. They were followed up for 3 months before treatment, 2 weeks and 4 weeks, respectively, after treatment, to evaluate the efficacy and function. The unified Parkinson's Disease Rating Scale (UPDRS) was used. Cognitive function assessment Monteller Cognitive Assessment Scale (MoCA); Barthel Index for daily living activities; Depression assessment Hamilton Depression Scale (HAMD); Hamilton Anxiety Scale (HAMA); Sleep assessment PD Sleep Scale (PDSS); Pain assessment King Parkinson's Pain Assessment (KPPS) and adverse events were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A total of 200 patients with Parkinson's disease were enrolled in each center and randomly divided into control group (routine treatment) and observation group (routine treatment +rTMS).
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Routine treatment in NeurologyAll participants were treated with routine treatment in Neurology. |
| Experimental group | Experimental | Device: Routine treatment in Neurology and rTMSAll participants were treated with routine treatment in Neurology and rTMS treatment. rTMS parameters were set to stimulate the site: bilateral primary motor cortex; Stimulus frequency :5Hz; Pulse number: 1000 pulses per day, 500 on the left and 500 on the right; Stimulus intensity :90% resting threshold; Coil: 70mm round coil; Once a day, 30 minutes each time, 5 days a week for 4 weeks |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Hoehn-YAHR classification is between 1 and 2；
- Have a primary school education or above and can read the scale used in this study;
- MoCA score between 20 and 24, mild cognitive impairment ;
- Aged between 30 and 80, regardless of gender；
- Voluntarily participate and sign informed consent.
Key exclusion criteria (7 listed)
- patients with cerebrovascular accident, craniocerebral injury and other diseases affecting muscle tension;
- patients with serious mental disorders and cognitive disorders who cannot cooperate with assessment;
- patients with severe liver, kidney, heart dysfunction and severe physical disorders;
- Implanted devices such as pacemakers are installed inside the body;
- drug-induced Parkinson's syndrome or Parkinson's superposition syndrome;
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 |
|---|---|---|
| Routine treatment in NeurologyRoutine treatment in Neurology department, including drug treatment,etc. | Other | Control group |
| Routine treatment in Neurology and rTMSAdd rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability | Device | Experimental group |
Primary outcome
Unified Parkinson's disease rating Scale （UPDRS）
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.
Montreal Cognitive Assessment Scale (MoCA)
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Full score of 30 points,>=26 points normal,. Mild cognitive impairment (MCI) on a scale of 18-26, moderate on a scale of 10-17, and severe on a scale of<10.
King's Parkinson's Pain Assessment (KPPS)
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Evaluate the pain degree and quality of life of patients with Parkinson's disease, including 14 items in 7 aspects, including skeletal muscle pain, Chronic pain, symptom fluctuation related pain, nocturnal pain, orofacial pain, distention pain, and nerve root pain. Each score is expressed as pain severity (0-3 levels) multiplied by frequency (0-4 levels), that is, 0-12 points. The total score is 168 points. The higher the score, the more severe the pain.
PD Sleep Scale (PDSS)
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Evaluate the patient's sleep status, with a total of 15 items on the scale. Each item is scored on a scale of 0-10 points, with a lower score indicating poorer sleep status.
Activities of daily living Assessment - Barthel
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
The total score of the index is 100 points, and the higher the score, the better the self-care ability and the less dependence. Those scoring above 60 can basically complete basic Activities of daily living, 59-41 need some help to complete, 40-21 need a lot of help. Those who score below 20 are in complete need of help and cannot take care of themselves.
2 secondary outcomes
Hamilton Depression Scale (HAMD)
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Hamilton Anxiety Scale (HAMA)
Time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- 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 Routine treatment in Neurology and Routine treatment in Neurology and rTMS in people with Parkinson's Disease, run by Affiliated Hospital of Nantong 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 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 24 Aug 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. 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 Aisong Guo (15851300188, guoasg@ntu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unified Parkinson's disease rating Scale （UPDRS） (time frame: The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.). The study lists 5 primary outcomes in all. 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 24 Aug 2023.