Parkinson's DiseaseNCT04041661
Concurrent Transcranial Direct Current Stimulation and Gait Training in Parkinson's Disease
A study testing Active tDCS plus gait training in people with Parkinson's Disease, run by National Yang Ming Chiao Tung University.
Trial summary
To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Active tDCS plus gait training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with idiopathic PD
- Hoehn and Yahr stages I-III
- Mini Mental Status Examination (MMSE) score ≧ 24
- Could walk 10m independently with or without gait aid
Who cannot join
- Concurrent medication likely to affect mental performance
- tDCS contraindication
- Significant neurological, vestibular, visual disorders or psychiatric illness
- Musculoskeletal or cardiopulmonary disease
- Sensory system pathology
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Concurrent Transcranial Direct Current Stimulation and Gait Training on Gait Performance When Doing the Cognitive Dual-task in People With Parkinson's Disease
To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease.
- Conditions
- Parkinson's Disease
- Being tested
- Active tDCS plus gait training, Sham tDCS plus gait training
- Keywords
- Dual task performance, Executive function, Transcrainal direct current stimulation (tDCS)
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active tDCS plus gait trainingOther
Participants in experimental group will accept Active tDCS which combined with treadmill
Sham tDCS plus gait trainingOther
Participants in control group will accept Sham tDCS which combined with treadmill
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS plus gait training group | Experimental | Participants in Active tDCS plus gait training group will execute Active tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks. Receives: Other: Active tDCS plus gait training |
| Sham tDCS plus gait training group | Sham comparator | Participants in Sham tDCS plus gait training group will executeSham tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks. Receives: Other: Sham tDCS plus gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dual-task walking performance
To evaluate gait parameters while doing dual-task walking
Measured: Change from baseline at 4 weeks
Secondary outcomes (4)
Single walking performance
To evaluate gait parameters while doing single walking
Measured: Change from baseline at 4 weeks
Trail-making test A & B
To evaluate executive function
Measured: Change from baseline at 4 weeks
Stroop color and word test-Chinese version
To evaluate executive function
Measured: Change from baseline at 4 weeks
Digit span test
To evaluate executive function
Measured: Change from baseline at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start1 Aug 2019 (estimated)
- Primary completion31 Aug 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by National Yang Ming Chiao Tung 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, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Yang Ming Chiao Tung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yea-Ru Yang, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041661
- Sponsor's protocol ID
- 19MMHIS113e
- Status last verified
- Aug 2019
- First submitted
- 31 Jul 2019
- Last updated
- 6 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Concurrent Transcranial Direct Current Stimulation and Gait Training on Gait Performance When Doing the Cognitive Dual-task in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04041661
- Acronym / sponsor ID
- 19MMHIS113e
- Conditions
- Parkinson's Disease
- Keywords
- Dual task performance, Executive function, Transcrainal direct current stimulation (tDCS)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Yang Ming Chiao Tung UniversityUniversity, hospital or other
- Study start
- 1 Aug 2019 (estimated)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 1 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate the effect of concurrent transcranial direct current stimulation and gait training on gait performance when doing the cognitive dual-task in people with Parkinson's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active tDCS plus gait training group | Experimental | Other: Active tDCS plus gait trainingParticipants in Active tDCS plus gait training group will execute Active tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks. |
| Sham tDCS plus gait training group | Sham comparator | Other: Sham tDCS plus gait trainingParticipants in Sham tDCS plus gait training group will executeSham tDCS on left dorsolateral prefrontal cortex which combined with treadmill, 12 times per week, least 4 weeks. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with idiopathic PD
- Hoehn and Yahr stages I-III
- Mini Mental Status Examination (MMSE) score ≧ 24
- Could walk 10m independently with or without gait aid
Key exclusion criteria (5 listed)
- Concurrent medication likely to affect mental performance
- tDCS contraindication
- Significant neurological, vestibular, visual disorders or psychiatric illness
- Musculoskeletal or cardiopulmonary disease
- Sensory system pathology
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 |
|---|---|---|
| Active tDCS plus gait trainingParticipants in experimental group will accept Active tDCS which combined with treadmill | Other | Active tDCS plus gait training group |
| Sham tDCS plus gait trainingParticipants in control group will accept Sham tDCS which combined with treadmill | Other | Sham tDCS plus gait training group |
Primary outcome
Dual-task walking performance
Time frame: Change from baseline at 4 weeks
To evaluate gait parameters while doing dual-task walking
4 secondary outcomes
Single walking performance
Time frame: Change from baseline at 4 weeks
Trail-making test A & B
Time frame: Change from baseline at 4 weeks
Stroop color and word test-Chinese version
Time frame: Change from baseline at 4 weeks
Digit span test
Time frame: Change from baseline at 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2019.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Active tDCS plus gait training in people with Parkinson's Disease, run by National Yang Ming Chiao Tung University.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 6 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yearu Yang, Ph.D (+88628267279, yryang@ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dual-task walking performance (time frame: Change from baseline at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Aug 2019.