Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment for Parkinson Disease

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Transcranial Magnetic Stimulation; Functional Magnetic Resonance Imaging
• Intervention / Treatment: Other: transcranial magnetic stimulation

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230032
      • Anhui Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Real Stimulation; Participants will receive active transcranial magnetic stimulation (TMS) daily for two weeks	Other: transcranial magnetic stimulation; The stimulations were performed by MagStim Rapid2.
Placebo Comparator: Placebo Stimulation; Participants will receive sham transcranial magnetic stimulation (TMS) daily for two weeks	Other: transcranial magnetic stimulation; The stimulations were performed by MagStim Rapid2.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Anhui Medical University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): January 1, 2019

Study Registration Dates

• First Submitted: November 17, 2016
• First Submitted That Met QC Criteria: November 17, 2016
• First Posted (Estimate): November 21, 2016

Study Record Updates

• Last Update Posted (Actual): March 20, 2019
• Last Update Submitted That Met QC Criteria: March 16, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Functional Magnetic Resonance Imaging; Transcranial Magnetic Stimulation; Parkinson Disease
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: NSFC-81171273-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO