Clinical trial NCT02701647: Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease
Official title: Repetitive Transcranial Magnetic Stimulation Promotes Gait Training in People With Parkinson's Disease - a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Transcranial Magnetic Stimulation
metaplasticity
gait training
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
First posted: 2016-03-08
Enrollment: 51
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with idiopathic Parkinson's disease by a neurologist
* had been stable on anti-Parkinsonian medication
* able to walk independently for 30 meters

Exclusion Criteria:

* severe co-morbidity that may interfere with their ability to participate including significant orthopaedic or rheumatological conditions or disorders of peripheral nervous systems that may interfere with mobility or balance performance
* a diagnosis of neurological disease other than PD
* a history of psychiatric disorders
* the impossibility of inducing motor evoked potentials (MEPs)
* a score of less than 24 on the Mini-Mental State Examination
* contraindication to TMS including personal or family history of seizure disorder, metal in the head, implants of medical devices such as cardiac pacemakers or medical pumps, females subjects who are pregnant, a history of neurosurgery
* subjects with irrepressible tremor and / or dyskinesia

Primary outcomes:
measure: Fastest Walking Speed
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention
Secondary outcomes:
measure: Timed-Up-and-Go Test (iTUG)
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
measure: the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
timeFrame: Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention
measure: Walking Distance in a 2 -Minute Walk Test
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
measure: Mini Balance Evaluation Systems Test Scores
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
measure: Dual-task Timed-Up-and-Go Test (DT-TUG)
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention
Other outcomes:
measure: Cortical Silent Period
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
measure: Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
measure: Short-interval-intracortical Inhibition
timeFrame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Locations:
city: Hong Kong
country: Hong Kong
facility: Rehabilitation Sciences
Study officials:
affiliation: The Hong Kong Polytechnic University
name: Margaret Mak, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang YR, Tseng CY, Chiou SY, Liao KK, Cheng SJ, Lai KL, Wang RY. Combination of rTMS and treadmill training modulates corticomotor inhibition and improves walking in Parkinson disease: a randomized trial. Neurorehabil Neural Repair. 2013 Jan;27(1):79-86. doi: 10.1177/1545968312451915. Epub 2012 Jul 10.