Back to resultsA Multicenter Clinical Study of rTMS for Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Routine treatment in Neurology
Routine treatment in Neurology and rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring 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)
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Sites / Locations
- rTMSRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Experimental group
Arm Description
All participants were treated with routine treatment in Neurology.
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
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT06009471
First Posted
June 25, 2023
Last Updated
August 20, 2023
Sponsor
Affiliated Hospital of Nantong University
1. Study Identification
Unique Protocol Identification Number
NCT06009471
Brief Title
A Multicenter Clinical Study of rTMS for Parkinson's Disease
Official Title
A Multicenter Clinical Study of rTMS for Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2023 (Actual)
Primary Completion Date
August 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Affiliated Hospital of Nantong University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
All participants were treated with routine treatment in Neurology.
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
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
Intervention Type
Other
Intervention Name(s)
Routine treatment in Neurology
Intervention Description
Routine treatment in Neurology department, including drug treatment,etc.
Intervention Type
Device
Intervention Name(s)
Routine treatment in Neurology and rTMS
Intervention Description
Add rTMS to routine treatment. Low frequency rTMS is often used to treat cortical hyperexcitability and high frequency rTMS to treat hypoexcitability
Primary Outcome Measure Information:
Title
Unified Parkinson's disease rating Scale （UPDRS）
Description
16 items, each with a score of 0-4, and the score is directly proportional to the severity of PD motor symptoms.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Title
Montreal Cognitive Assessment Scale (MoCA)
Description
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.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Title
King's Parkinson's Pain Assessment (KPPS)
Description
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.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Title
PD Sleep Scale (PDSS)
Description
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.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Title
Activities of daily living Assessment - Barthel
Description
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.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Secondary Outcome Measure Information:
Title
Hamilton Depression Scale (HAMD)
Description
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.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
Title
Hamilton Anxiety Scale (HAMA)
Description
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.
Time Frame
The assessments are conducted at the baseline, 2nd week, 4th week, and 3 months after the end of treatment.
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
self-representation of gender identity
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aisong Guo
Phone
15851300188
Email
guoasg@ntu.edu.cn
Facility Information:
Facility Name
rTMS
City
Nantong
State/Province
Jiangsu
ZIP/Postal Code
226001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aisong Guo
Phone
15851300188
Email
guoasg@ntu.edu.cn
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Multicenter Clinical Study of rTMS for Parkinson's Disease
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