Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional

Summary: 
      The purpose of this study is to investigate whether the beneficial effect of treadmill
      training on people with Parkinson's disease can be enhanced by high- and low-frequency
      repetitive transcranial magnetic stimulation (rTMS).
    

Detailed description: 
      This is a randomised placebo-controlled trial. Fifty-one participants with Parkinson's
      disease (PD) will be recruited from the Hong Kong PD association, a self-help group and
      movement disorders clinic of 3 local hospitals. Written informed consent in accordance with
      the Declaration of Helsinki will be obtained from all participants. Eligible participants
      will be randomly assigned into one of the three groups: 1Hz-TT, 25Hz-TT, and sham-TT upon
      recruitment. Randomisation will be generated by a computer program and group assignment will
      be blinded to both participants and assessor. Participant will receive either 1-Hz, 25-Hz, or
      sham rTMS which will last for about 20 minutes followed by 30 minutes treadmill walking
      training for 12 sessions, 4 times per week for 3 weeks. All assessments will be conducted 1
      week before intervention and 1 day after completion of intervention, after 1-month training
      and at 3-month post training.

      The sample size calculation is based on the significant findings of the gait speed reported
      by Yang et al (2013). A two-way repeated measures ANOVA design with between-subject group
      effect (3 levels) and within-subject time effect (4 levels) determines that 15 subjects per
      group are required to achieve 85% power to test the interaction effect between groups and
      time effect with a 5% significance level and the effect size is 0.2. By assuming 10% dropout
      rate, 17 subjects will be required per group.
    

Intervention name(s): Repetitive transcranial magnetic stimulation (rTMS); Treadmill training
Intervention type(s): Device; Other
Intervention description(s): Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.; Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Participants will maintain the maximum speed achieved for the rest of the session or adjusted as needed. Positive verbal feedback will be given to encourage large strides and upright posture during training. The participants will be instructed to walk on treadmill without holding onto the handrails if possible. Participants will perform warm up and cool down exercise to minimize training related-injury.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Transcranial Magnetic Stimulation; metaplasticity; gait training