Parkinson's DiseaseNCT02701647
Effects of Combined rTMS and Treadmill Training in People With Parkinson's Disease
A study testing Repetitive transcranial magnetic stimulation (rTMS) and Treadmill training in people with Parkinson's Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) and Treadmill training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 51 participants
- Where
- 1 siteHong Kong
- Study dates
- Oct 2016to May 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic Parkinson's disease by a neurologist
- had been stable on anti-Parkinsonian medication
- able to walk independently for 30 meters
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Promotes Gait Training in People With Parkinson's Disease - a Randomised Controlled Trial
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).
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), Treadmill training
- Keywords
- Transcranial Magnetic Stimulation, metaplasticity, gait training
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Device
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.
Treadmill trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 25Hz-TT | Experimental | 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. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS); Other: Treadmill training |
| 1Hz-TT | Experimental | 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. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS); Other: Treadmill training |
| Sham-TT | Sham comparator | 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. Receives: Device: Repetitive transcranial magnetic stimulation (rTMS); Other: Treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention
Secondary outcomes (5)
Timed-Up-and-Go Test (iTUG)
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.
Time and gait parameters during TUG were captured by the valid and reliable APDM system, which is a wearable gait and balance analysis system.
Measured: 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)
MDS-UPDRS III is a valid and reliable clinical test, will be used to evaluate severity of motor symptoms of PD. There are total of 27 items including tremor, rigidity, bradykinesia, postural instability and gait performance. Each item scores from 0-4, with 0 indicates no disability and 4 maximum disabled with total score(s) ranges from 0 to 132.
Measured: Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention
Walking Distance in a 2 -Minute Walk Test
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.
Measured: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Mini Balance Evaluation Systems Test Scores
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. The Total scores range from 0-28, with higher scores indicate better dynamic balance.
Measured: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Dual-task Timed-Up-and-Go Test (DT-TUG)
For DT-TUG, participants were instructured to repeat the TUG procedure while performing a serial three substraction. Time taken to complete DT-TUG and accuracy of digital counting was recorded. One practice trial was given prior to both TUG and DT-TUG testing and average performance of three trials was used for analysis.
Measured: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2018
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by The Hong Kong Polytechnic UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Margaret Mak, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701647
- Sponsor's protocol ID
- HSEARS20140423002
- Status last verified
- Jun 2018
- First submitted
- 19 Jan 2016
- Last updated
- 22 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be shared with researcher who provide a methodologically sound proposal
Publications
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.
PubMed 22785003
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Promotes Gait Training in People With Parkinson's Disease - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT02701647
- Acronym / sponsor ID
- HSEARS20140423002
- Conditions
- Parkinson's Disease
- Keywords
- Transcranial Magnetic Stimulation, metaplasticity, gait training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 31 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 25Hz-TT | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS), Other: Treadmill trainingParticipants 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 | Experimental | Device: Repetitive transcranial magnetic stimulation (rTMS), Other: Treadmill trainingParticipants 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 comparator | Device: Repetitive transcranial magnetic stimulation (rTMS), Other: Treadmill trainingSham 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed with idiopathic Parkinson's disease by a neurologist
- had been stable on anti-Parkinsonian medication
- able to walk independently for 30 meters
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)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. | Device | 1Hz-TT, 25Hz-TT, Sham-TT |
| Treadmill trainingParticipants 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. | Other | 1Hz-TT, 25Hz-TT, Sham-TT |
Primary outcome
Fastest Walking Speed
Time frame: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention
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.
5 secondary outcomes
Timed-Up-and-Go Test (iTUG)
Time frame: 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)
Time frame: Baseline, I day post-intervention, 1 month post-intervention and 3 months post-intervention
Walking Distance in a 2 -Minute Walk Test
Time frame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Mini Balance Evaluation Systems Test Scores
Time frame: Baseline, 1 day post-intervention, 1 month post-intervention and 3 months post-intervention
Dual-task Timed-Up-and-Go Test (DT-TUG)
Time frame: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month-post intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22785003Yang 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.
- Individual participant dataSharing planned: Yes. Data will be shared with researcher who provide a methodologically sound proposal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Margaret Mak, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) and Treadmill training in people with Parkinson's Disease, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fastest Walking Speed (time frame: Baseline, 1 day post-intervention, 1 month post-intervention, 3 month post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02701647, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.