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CompletedNCT04154397PUpdated Nov 6, 2019

Posture Training and Cerebellar Stimulation in Elderly People

An interventional study of cerebellar transcranial stimulation in Transcranial Electrical Stimulation, sponsored by National Cheng-Kung University Hospital. Completed. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-06.

Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Registered 4 years 5 months after the study started (first participant enrolled May 2015, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
60 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Transcranial Electrical Stimulation

Keywords

  • Motor learning
  • Cerebellum transcranial electrical stimulation
  • Postural balance
  • Error feedback
  • Electroencephalography
  • Elderly
03

In context

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (actual)

Study arms

  • No intervention
    error-enhancing feedback

    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.

  • Experimental
    positive cerebellar transcranial stimulation

    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.

    Device: cerebellar transcranial stimulation

  • Experimental
    sham cerebellar transcranial stimulation

    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.

    Device: cerebellar transcranial stimulation

Interventions

  • Devicecerebellar transcranial stimulation

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: through study completion, an average of 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 6, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04154397
Lead sponsor
National Cheng-Kung University Hospital
Responsible party
Sponsor
First posted
Nov 6, 2019
Start date
May 20, 2015
Primary completion
Jan 24, 2019
Completion
Sep 30, 2019
Last update
Nov 6, 2019

Study contacts

Hwang Ing-Shiou, Phd
study chair · NCKU, Institute of Allied Health Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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