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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02969941
Other study ID # NSFC-81171273-02
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2016
Est. completion date January 1, 2019

Study information

Verified date March 2019
Source Anhui Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the treatment effect of continuous transcranial magnetic stimulation on patients with Parkinson disease, and the underlying neural mechanism by functional MRI


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.


Recruitment information / eligibility

Status Completed
Enrollment 46
Est. completion date January 1, 2019
Est. primary completion date January 1, 2019
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Functional Magnetic Resonance Imaging
  • Parkinson Disease
  • Transcranial Magnetic Stimulation

Intervention

Other:
transcranial magnetic stimulation
The stimulations were performed by MagStim Rapid2.

Locations

Country Name City State
China Anhui Medical University Hefei Anhui

Sponsors (1)

Lead Sponsor Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. changes from baseline at 2 weeks post-treatment
Secondary 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. changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Secondary 20m walking test The patients were requested to walk, but not run, for a distance of 20 meters, turn around, walk back again. changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Secondary 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. changes from baseline at 1, 2, 4, 6 and 10 weeks post-treatment
Secondary 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. changes from baseline at 1, 4, 6, and 10 weeks post-treatment
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