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Effects of Combined rTMS and Treadmill Training on Walking in PD

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ClinicalTrials.gov Identifier: NCT02701647
Recruitment Status : Active, not recruiting
First Posted : March 8, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

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 repetitive transcranial magnetic stimulation (rTMS).

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: repetitive transcranial magnetic stimulation Other: Treadmill training Not Applicable

Detailed Description:
This is a single-blinded randomized placebo-controlled trial. Sixty-six participants with Parkinson's disease (PD) will be recruited from the Hong Kong PD association, a self-help group and movement disorder clinics 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: 1-Hz, 25-Hz, and sham rTMS upon recruitment. Randomization was 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 was calculated using G* power 3 statistical analysis software. A two-way repeated measures ANOVA design with between-subject group effect (3 levels) and within-subject effect (4 levels) determines that 20 subjects per group are required to achieve 80% power to test the interaction effect between group and time effect with a 5 % significance level and the effect size of 0.5. By assuming 10% dropout rate, 22 subjects will be required per group.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Combined Repetitive Transcranial Magnetic Stimulation and Treadmill Training on Gait Performance in Parkinson's Disease: A Randomised Controlled Trial
Actual Study Start Date : February 2016
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 25-Hz rTMS
Participants will receive 4s train of 25-Hz repetitive Transcranial magnetic stimulation pulses with 50s inter-train intervals. 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.
Device: repetitive transcranial magnetic stimulation
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 filed in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim 200 magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.

Other: Treadmill training
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. Maximum achieved speed will be maintained followed by 0.5 km/h decrements. Participants will maintain the rest of the treadmill session with this speed or further adjustment will be made if participants are unable to maintain. 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.

Experimental: 1-Hz rTMS
Participants will receive a total of 600 1-Hz repetitive Transcranial magnetic stimulation pulses in 10 minutes for each hemisphere and a total of 1200 pulses followed by 30 minutes of treadmill training.
Device: repetitive transcranial magnetic stimulation
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 filed in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim 200 magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.

Other: Treadmill training
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. Maximum achieved speed will be maintained followed by 0.5 km/h decrements. Participants will maintain the rest of the treadmill session with this speed or further adjustment will be made if participants are unable to maintain. 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.

Sham Comparator: Sham rTMS
Sham repetitive Transcranial magnetic stimulation will be applied over the same site as for real rTMS , however, with the cables of the coil disconnected. Another figure-of-eight coil using the same stimulation parameters (intensity, time, and frequency) as 25-Hz group will be placed posterior to the subject's neck with the handle pointing backward to produce the same clicking sound effect as 25-Hz group. Sham rTMS will be followed by 30 minutes of treadmill training.
Device: repetitive transcranial magnetic stimulation
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 filed in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim 200 magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.

Other: Treadmill training
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. Maximum achieved speed will be maintained followed by 0.5 km/h decrements. Participants will maintain the rest of the treadmill session with this speed or further adjustment will be made if participants are unable to maintain. 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.




Primary Outcome Measures :
  1. Change in time taken to complete the instrumented Timed-Up-and-Go Test (iTUG) [ Time Frame: Baseline, 1 month and 3 months ]
    Participants are instructed to stand up from a chair and walk for 7 meters walkway and return back to the chair turn around and sit down in both single task and dual task conditions. In dual task condition, participants will repeat the 7-meter iTUG while continuing a serial three subtractions.


Secondary Outcome Measures :
  1. Change in MiniBESTest scores [ Time Frame: Baseline, 1 month and 3 months ]
    Balance performance of participants will be assessed in 4 domains namely anticipatory postural adjustments, postural responses, sensory orientation and gait stability. Each item is rated from 0-2 with a total scores of 28. Higher scores indicate better dynamic balance.

  2. Change in cortical silent period [ Time Frame: Baseline, 1 month and 3 months ]
    Ten suprathreshold TMS stimulus will be delivered while participant performing a 20% isometric maximal contraction of Tibialis Anterior. Cortical silent period measures the duration of interruption of electromyography (EMG) activity in the contracting muscle produced by TMS.

  3. Change in gradient of the recruitment curve ( also known as stimulus-response curve) [ Time Frame: Baseline, 1 month and 3 months ]
    TMS stimuli will be applied at 10% steps between 100% to 160% motor threshold. 10 stimuli will be delivered at each intensity. Peak to peak amplitude of 10 motor-evoked potentials (MEPs) at each stimulus intensity will be averaged offline. A scatter graph will be generated with the average amplitude of MEPs as a function of stimulation intensity. The linear trend will be added to generate the linear recruitment curve slope.

  4. Change in Short-interval-intracortical inhibition [ Time Frame: Baseline, 1 month and 3 months ]
    Short-interval-intracortical inhibition is another measure of cortical inhibition. In a pair TMS pulse paradigm, a test pulse will be adjusted to produce MEPs of at least 0.5 micro-volts which will be delivered preceded by a brief conditioned pulse set at a lower intensity of 80% of the resting motor threshold with inter-stimulus interval of 2 milliseconds. Two stimulators connected via a Bistim module ( Magstim Co.,Whitland, Carmarthenshire, Wales) will be used in this test.

  5. Change in walking distance in a 2 -minute walk test [ Time Frame: Baseline, 1 month and 3 months ]
    The 2 minute walk test will be conducted along a 20 m x 2 m hallway. A line is marked at each end of the walkway to indicate where the person is to turn. Participants will be instructed to " walk as far as possible in 2 minutes". They will be given standardised encouragement at 60 and 90 seconds during walk. Distance walked will be recorded to the nearest meter.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with idiopathic Parkinson's disease by a neurologist
  • Hoehn and Yahr Scale Stage I-III with stable medication usage
  • able to walk independently with or without aids for 10 meters

Exclusion Criteria:

  • severe co-morbidity that may interfere with their ability to participate
  • significant orthopedic or rheumatological conditions or disorders of peripheral nervous systems that may interfere with mobility or balance performance
  • Females subjects who are pregnant
  • Neurological disease other than PD
  • a score of less than 23 on the Mini-Mental State Examination
  • any auditory or visual impairment
  • History of neurosurgery
  • 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 subjects with irrepressible tremor and//or dyskinesia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02701647


Locations
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Hong Kong
Rehabilitation Sciences
Hong Kong, Hong Kong, 852
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Margaret Mak, PhD The Hong Kong Polytechnic University

Publications:
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT02701647     History of Changes
Other Study ID Numbers: HSEARS20140423002
First Posted: March 8, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by The Hong Kong Polytechnic University:
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases