Transcranial Electrical StimulationPNCT04154397
Posture Training and Cerebellar Stimulation in Elderly People
A study testing cerebellar transcranial stimulation in people with Transcranial Electrical Stimulation, run by National Cheng-Kung University Hospital.
Trial summary
Motor learning relies on both feedback and feedforward mechanisms to keep progressive optimization of motor behaviors in a coordinated manner. Error correction based on the fronto-parietal loop is subject to error information inherent within visual feedback. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Transcranial Electrical Stimulation
- What is being tested?
- cerebellar transcranial stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 20 May 2015to 30 Sep 2019
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age above 60 years old healthy older adults without a history of falls.
- Able to understand and give informed consent.
- The Mini-Mental State Examination test score above 25-30.
- Lower limb muscle strength is evaluated as G grade
- The corrected visual acuity was within the normal range.
Who cannot join
- Any known history of mental illness
- Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
- Any known history of cerebral cerebellar disease or intracranial metal implants.
- Weak of hearing or wearing a hearing aid
About this study
Official title: Enhancement of Posture Training Effectiveness With Error-enhancing Feedback and Cerebellar Stimulation
Motor learning relies on both feedback and feedforward mechanisms to keep progressive optimization of motor behaviors in a coordinated manner. Error correction based on the fronto-parietal loop is subject to error information inherent within visual feedback. On the other hand, cerebellar activity for restoration of efferent copy involves in operation of feedforward mechanism. Therefore, the amount of error feedback and excitation of cerebellum are keyed to effectiveness of motor learning. Although postural training is of empirical value to prevent falling from the elderly, yet none of previous studies have ever been devoted to improve effectiveness of postural training via manipulations of visual error feedback and cerebellar stimulation.
From the aspect of cognition-motor interaction, the present proposal is a three-year project intended to promote effectiveness of postural training for the elderly. In the first year, feedback-based training benefits from a dynamic postural task under the conditions of different visual size of error feedback (error-reducing feedback, error-enhancing feedback, and fixed error feedback) will be contrasted. In the second year, feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) will be contrasted. In the third year, the proposal will examine whether postural training with combined approach (error-enhancing feedback and ctDCS) could result in a superior training benefit to those of error-enhancing feedback alone and ctDCS alone approaches. In addition to innovative training intervention, this proposal will make use of current non-linear analyses on EEG signals and postural sway with graph analysis and heading analysis, respectively. It is expected to gain additional insight into behavior and brain mechanisms underlying learning-related changes with the postural training, potentially lending to a more effective training paradigm for postural stability of the elderly.
- Conditions
- Transcranial Electrical Stimulation
- Being tested
- cerebellar transcranial stimulation
- Keywords
- Motor learning, Cerebellum transcranial electrical stimulation, Postural balance, Error feedback, Electroencephalography, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cerebellar transcranial stimulationDevice
Feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) were administered using a one-channel direct current stimulator (NeuroConn DC-Stimulator PlusTM) with study mode enabled for single blinding. Following the baseline trial of posture tracking, participants of three groups were seated in a chair for 20 min to receive either active or sham cerebellar tDCS prior to the posture tracking and transfer test phases.
| Study group | Role | What they receive |
|---|---|---|
| error-enhancing feedback | No intervention | The project of the first arm was to investigate how visualized error size affects postural training effect of the elderly, with a particular focus on error amplification strategy to optimize training benefits for postural training that favors the use of feedback mechanism on postural control and error correction. All participants were randomly assigned into the control and error amplification groups. The control group was trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. For the error amplification group, they were trained with the same postural paradigm, except that the visual guidance was virtually manipulated so that the participants visually perceived twice of the execution errors during stabilometer stance. We contrasted training benefits between the two groups after completion of eight training trails of 1 minute. |
| positive cerebellar transcranial stimulation | Experimental | The project of the second arm was to investigate the training benefits of using combined cerebellar transcranial direct current stimulation and visual error amplification on postural training during static stabilometer stance, in reference to sole visual error amplification. A particular focus was training-related alterations in error correction strategy and underlying cortical plasticity for postural balance.They were randomly assigned into the control (traditional error amplification)and cerebellar transcranial direct current stimulation groups. Both groups were trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. Under the condition of visual feedback without error amplification, we again contrasted training benefits between the two groups after completion of eight training trails of 1 minute. Receives: Device: cerebellar transcranial stimulation |
| sham cerebellar transcranial stimulation | Experimental | The project of the third arm was to investigate the training benefits of using combined cerebellar transcranial random current stimulation and visual error amplification on postural training during static stabilometer stance, in reference to sole visual error amplification. A particular focus was training-related alterations in error correction strategy and underlying cortical plasticity for postural balance. All participants were randomly assigned into the control (sham stimulation) and cerebellar transcranial random current stimulation and visual error amplification (ES) groups. Both groups were trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. Under the condition of visual feedback without error amplification, we again contrasted training benefits between the two groups after completion of eight training trails of 1 minute. Receives: Device: cerebellar transcranial stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graph theoretical analysis of EEG functional network
Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer.This project introduced EEG pattern analysis into the posture research project. It is expected to find out the changes in brain network efficiency and functional structure caused by posture training. It is a tool for understanding the neural mechanism of this project.
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
heading analysis of center of pressure
Trajectories of central of pressure will be analyzed with stabilogram diffusion analysis to reveal behavior mechanisms for practice-related variations in feedback and feedforward process for error corrections.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2019
- Study start20 May 2015
- Primary completion24 Jan 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transcranial Electrical StimulationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hwang Ing-Shiou, Phd, Study chair, NCKU, Institute of Allied Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04154397
- Sponsor's protocol ID
- MOST 105-2314-B-006 -014 -MY3
- Acronym
- P
- Status last verified
- Oct 2019
- First submitted
- 28 Oct 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Posture Training Effectiveness With Error-enhancing Feedback and Cerebellar Stimulation
- ClinicalTrials.gov ID
- NCT04154397
- Acronym / sponsor ID
- P / MOST 105-2314-B-006 -014 -MY3
- Conditions
- Transcranial Electrical Stimulation
- Keywords
- Motor learning, Cerebellum transcranial electrical stimulation, Postural balance, Error feedback, Electroencephalography, Elderly
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 20 May 2015 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 6 Nov 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.
Motor learning relies on both feedback and feedforward mechanisms to keep progressive optimization of motor behaviors in a coordinated manner. Error correction based on the fronto-parietal loop is subject to error information inherent within visual feedback. On the other hand, cerebellar activity for restoration of efferent copy involves in operation of feedforward mechanism. Therefore, the amount of error feedback and excitation of cerebellum are keyed to effectiveness of motor learning. Although postural training is of empirical value to prevent falling from the elderly, yet none of previous studies have ever been devoted to improve effectiveness of postural training via manipulations of visual error feedback and cerebellar stimulation.
From the aspect of cognition-motor interaction, the present proposal is a three-year project intended to promote effectiveness of postural training for the elderly. In the first year, feedback-based training benefits from a dynamic postural task under the conditions of different visual size of error feedback (error-reducing feedback, error-enhancing feedback, and fixed error feedback) will be contrasted. In the second year, feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) will be contrasted. In the third year, the proposal will examine whether postural training with combined approach (error-enhancing feedback and ctDCS) could result in a superior training benefit to those of error-enhancing feedback alone and ctDCS alone approaches. In addition to innovative training intervention, this proposal will make use of current non-linear analyses on EEG signals and postural sway with graph analysis and heading analysis, respectively. It is expected to gain additional insight into behavior and brain mechanisms underlying learning-related changes with the postural training, potentially lending to a more effective training paradigm for postural stability of the elderly.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| error-enhancing feedback | No intervention | –The project of the first arm was to investigate how visualized error size affects postural training effect of the elderly, with a particular focus on error amplification strategy to optimize training benefits for postural training that favors the use of feedback mechanism on postural control and error correction. All participants were randomly assigned into the control and error amplification groups. The control group was trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. For the error amplification group, they were trained with the same postural paradigm, except that the visual guidance was virtually manipulated so that the participants visually perceived twice of the execution errors during stabilometer stance. We contrasted training benefits between the two groups after completion of eight training trails of 1 minute. |
| positive cerebellar transcranial stimulation | Experimental | Device: cerebellar transcranial stimulationThe project of the second arm was to investigate the training benefits of using combined cerebellar transcranial direct current stimulation and visual error amplification on postural training during static stabilometer stance, in reference to sole visual error amplification. A particular focus was training-related alterations in error correction strategy and underlying cortical plasticity for postural balance.They were randomly assigned into the control (traditional error amplification)and cerebellar transcranial direct current stimulation groups. Both groups were trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. Under the condition of visual feedback without error amplification, we again contrasted training benefits between the two groups after completion of eight training trails of 1 minute. |
| sham cerebellar transcranial stimulation | Experimental | Device: cerebellar transcranial stimulationThe project of the third arm was to investigate the training benefits of using combined cerebellar transcranial random current stimulation and visual error amplification on postural training during static stabilometer stance, in reference to sole visual error amplification. A particular focus was training-related alterations in error correction strategy and underlying cortical plasticity for postural balance. All participants were randomly assigned into the control (sham stimulation) and cerebellar transcranial random current stimulation and visual error amplification (ES) groups. Both groups were trained to remain static stance on the stabilometer with visual guidance that displayed the target signal and tilting angle of the stabilometer. Under the condition of visual feedback without error amplification, we again contrasted training benefits between the two groups after completion of eight training trails of 1 minute. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age above 60 years old healthy older adults without a history of falls.
- Able to understand and give informed consent.
- The Mini-Mental State Examination test score above 25-30.
- Lower limb muscle strength is evaluated as G grade
- The corrected visual acuity was within the normal range.
Key exclusion criteria (4 listed)
- Any known history of mental illness
- Any neuromuscular or degenerative neurological disease(ex:stroke、SCI、TBI...etc)
- Any known history of cerebral cerebellar disease or intracranial metal implants.
- Weak of hearing or wearing a hearing aid
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 |
|---|---|---|
| cerebellar transcranial stimulationFeedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) were administered using a one-channel direct current stimulator (NeuroConn DC-Stimulator PlusTM) with study mode enabled for single blinding. Following the baseline trial of posture tracking, participants of three groups were seated in a chair for 20 min to receive either active or sham cerebellar tDCS prior to the posture tracking and transfer test phases. | Device | positive cerebellar transcranial stimulation, sham cerebellar transcranial stimulation |
Primary outcome
Graph theoretical analysis of EEG functional network
Time frame: through study completion, an average of 1 year
Graph theory will characterize EEG functional connectivity and brain network efficiency regarding to brain mechanisms for practice-related leaning transfer.This project introduced EEG pattern analysis into the posture research project. It is expected to find out the changes in brain network efficiency and functional structure caused by posture training. It is a tool for understanding the neural mechanism of this project.
1 secondary outcome
heading analysis of center of pressure
Time frame: through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 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.
Hwang Ing-Shiou, Phd study chair
NCKU, Institute of Allied Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing cerebellar transcranial stimulation in people with Transcranial Electrical Stimulation, run by National Cheng-Kung University Hospital.
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 5 inclusion and 4 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 6 Nov 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Graph theoretical analysis of EEG functional network (time frame: through study completion, an average of 1 year). 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 Nov 2019.