Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease

The Hong Kong Polytechnic University

Status: Completed

Conditions: Parkinson's Disease

Treatments: Device: Repetitive transcranial magnetic stimulation (rTMS); Other: Treadmill training

Study type: Interventional

Funder types: Other

Identifiers

NCT02701647

HSEARS20140423002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 51 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 3 patient groups

25Hz-TT

Experimental group

Description:

Participants will receive 4s train of 25-Hz rTMS pulses with 50s inter-train interval, with an intensity of 80% resting motor threshold (RMT). Participant will receive a total of 600 rTMS pulses in 6 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS)

Other: Treadmill training

1Hz-TT

Experimental group

Description:

Participants will receive a total of 600 1-Hz rTMS pulses in 10 minutes for each hemisphere and a total of 1200 pulses ,with an intensity of 80% RMT, followed by 30 minutes of treadmill training.

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS)

Other: Treadmill training

Sham-TT

Sham Comparator group

Description:

Sham rTMS will be applied over the same site as for real rTMS, however, with the cable of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as per 25Hz-TT group will be placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect. Sham rTMS will be followed by 30 minutes of treadmill training.

Treatment:

Device: Repetitive transcranial magnetic stimulation (rTMS)

Other: Treadmill training