Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease
Primary Purpose
Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcranial magnetic stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Transcranial Magnetic Stimulation focused on measuring Parkinson Disease, Functional Magnetic Resonance Imaging, Transcranial Magnetic Stimulation
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of Parkinson disease (PD) according to the United Kingdom Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders.
- Minimum of 3 years since the formal diagnosis of PD, and requiring dopaminergic therapy (at a minimum, on levodopa and/or dopamine agonist therapy).
- On a stable dose of all medications for 2 months; and no anti-PD medication adjustments in the next 3 months.
- Age 40 years or older.
- Mini-mental state examination > 27.
Exclusion Criteria:
- Any history or clinical signs of other severe psychiatric illnesses (like major depression, psychosis or obsessive compulsive disorder).
- History of head injury, stroke, or other neurologic disease.
- Organic brain defects on T1 or T2 images.
- History of seizures or unexplained loss of consciousness.
- Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator.
- Family history of medication refractory epilepsy.
- History of substance abuse within the last 6 months.
Sites / Locations
- Anhui Medical University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Real Stimulation
Placebo Stimulation
Arm Description
Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks
Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks
Outcomes
Primary Outcome Measures
Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III
This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
Secondary Outcome Measures
Timed up and go test
Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
20m walking test
The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again.
Non-motor symptoms questionnaire
This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity"and "frequency" range from 0 to 3. Higher scores indicate worse symptoms.
Unified Parkinson's Disease Rating Scale III
This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.
Full Information
NCT ID
NCT02969941
First Posted
November 17, 2016
Last Updated
March 16, 2019
Sponsor
Anhui Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02969941
Brief Title
Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2016 (undefined)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
January 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI
Detailed Description
All patients underwent a medical evaluation that included physical examination and routine laboratory studies before and after repetitive transcranial magnetic stimulation (rTMS) treatment. Patients were randomly allocated to rTMS group and the sham group by coin toss. There are at least 20 patients in each group. The decision to enroll a patient was always made prior to randomization. Patients were studied using a double-blind design. Study participants, clinical raters, and all personnel responsible for the clinical care of the patient remained masked to allocated condition and allocation parameters. Only rTMS administrators had access to the randomization list; they had minimal contact with the patients, and no role in assessing clinical symptoms. Each patient would be treated for continuous 14 days by rTMS.
Before the rTMS treatment, the Unified Parkinson's Disease Rating Scale, and the Non-motor Symptom Scale were obtained by a trained investigator to assess baseline severity. The patients had receiving a battery measure of neuropsychological tests(mini-mental state examination, Montreal cognitive assessment, digital span test, verbal fluency test, Hamilton depression/anxiety scale, Stroop test, Iowa gambling test, game of dice test, stop signal test, and delay discount), magnetic resonance imaging scan in multimodalities, and electroencephalography (EEG) record.
In the second day after the last treatment, all the tests were reassessed. Patients were instructed to focus their answers on the past 14 days. The patients had also receiving a battery measure of neuropsychological tests, magnetic resonance imaging scan in multimodalities, and EEG record.
The clinical symptom and cognition of participants were followed in two month after the last treatment. They were instructed to focus their answers on the past week. Additionally, they were also asked to assess the battery of neuropsychological tests, and have magnetic resonance imaging scan in multimodalities, and EEG record. Afterwards, they were unblinded by the study coordinator.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Magnetic Stimulation, Functional Magnetic Resonance Imaging, Parkinson Disease
Keywords
Parkinson Disease, Functional Magnetic Resonance Imaging, Transcranial Magnetic Stimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real Stimulation
Arm Type
Active Comparator
Arm Description
Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks
Arm Title
Placebo Stimulation
Arm Type
Placebo Comparator
Arm Description
Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks
Intervention Type
Other
Intervention Name(s)
transcranial magnetic stimulation
Intervention Description
The stimulations were performed by MagStim Rapid2.
Primary Outcome Measure Information:
Title
Symptom improvement assessed by Unified Parkinson's Disease Rating Scale III
Description
This is an very common clinical motor estimating scale with 14 items and 108' in total. Higher scores indicate worse symptoms.
Time Frame
changes from baseline at 2 weeks post-treatment
Secondary Outcome Measure Information:
Title
Timed up and go test
Description
Time was taken by an individual to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again.
Time Frame
changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Title
20m walking test
Description
The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again.
Time Frame
changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Title
Non-motor symptoms questionnaire
Description
This is a very common clinical scale with nine domains (30 items). Each item was scored on "severity"and "frequency" range from 0 to 3. Higher scores indicate worse symptoms.
Time Frame
changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Title
Unified Parkinson's Disease Rating Scale III
Description
This is an very common clinical motor estimating scale, 14 items and 108' in total. Higher scores indicate worse symptoms.
Time Frame
changes from baseline at 1, 4, 6, and 10 weeks post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of Parkinson disease (PD) according to the United Kingdom Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders.
Minimum of 3 years since the formal diagnosis of PD, and requiring dopaminergic therapy (at a minimum, on levodopa and/or dopamine agonist therapy).
On a stable dose of all medications for 2 months; and no anti-PD medication adjustments in the next 3 months.
Age 40 years or older.
Mini-mental state examination > 27.
Exclusion Criteria:
Any history or clinical signs of other severe psychiatric illnesses (like major depression, psychosis or obsessive compulsive disorder).
History of head injury, stroke, or other neurologic disease.
Organic brain defects on T1 or T2 images.
History of seizures or unexplained loss of consciousness.
Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator.
Family history of medication refractory epilepsy.
History of substance abuse within the last 6 months.
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
State/Province
Anhui
ZIP/Postal Code
230032
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
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Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease
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