Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease
Repetitive Transcranial Magnetic Stimulation Promotes Gait Training in People With Parkinson's Disease - a Randomised Controlled Trial
1 other identifier
interventional
51
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2016
CompletedFirst Posted
Study publicly available on registry
March 8, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2019
CompletedResults Posted
Study results publicly available
October 31, 2019
CompletedNovember 22, 2019
June 1, 2018
2.2 years
January 19, 2016
February 21, 2019
November 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fastest Walking Speed
Each participant is instructed to walk for 14 meters at their fastest walking speed for three trials. The time taken for the middle 10 meter was recorded. The average of three trials is used for analysis.
Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention
Secondary Outcomes (5)
Timed-Up-and-Go Test (iTUG)
Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
the Motor Section of Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS III)
Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention
Walking Distance in a 2 -Minute Walk Test
Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Mini Balance Evaluation Systems Test Scores
Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Dual-task Timed-Up-and-Go Test (DT-TUG)
Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention
Other Outcomes (3)
Cortical Silent Period
Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Gradient of the Recruitment Curve ( Also Known as Stimulus-response Curve)
Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Short-interval-intracortical Inhibition
Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Study Arms (3)
25Hz-TT
EXPERIMENTALParticipants 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.
1Hz-TT
EXPERIMENTALParticipants 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.
Sham-TT
SHAM COMPARATORSham 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Diagnosed with idiopathic Parkinson's disease by a neurologist
- had been stable on anti-Parkinsonian medication
- able to walk independently for 30 meters
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Rehabilitation Sciences
Hong Kong, 852, Hong Kong
Related Publications (1)
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.
PMID: 22785003BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chloe Chung
- Organization
- The Hong Kong Polytechnic University
Study Officials
- PRINCIPAL INVESTIGATOR
Margaret Mak, PhD
The Hong Kong Polytechnic University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2016
First Posted
March 8, 2016
Study Start
October 1, 2016
Primary Completion
December 1, 2018
Study Completion
May 1, 2019
Last Updated
November 22, 2019
Results First Posted
October 31, 2019
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Beginning 3 months and ending 3 years following article publication
- Access Criteria
- request through email
Data will be shared with researcher who provide a methodologically sound proposal