NCT03328455

Brief Summary

In recent years evidence has accumulated on the association between age-related decline in multisensory temporal processing and postural control. This proposed project aims at examining GABA-mediated inhibition as the potential mechanism behind this link. Our overarching hypothesis is that changes in the excitatory-inhibitory balance with a reduction of GABAergic inhibition is a common mechanism underlying age-related multisensory and postural deficits potentially mediated by age-related reduction in network segregation. To test this hypothesis, we will assess the relationship between age-related multisensory/postural deficits and age-related reduction in GABA concentration in related brain areas and probe the role of GABA-mediated inhibition using cognitive training that specifically targets inhibitory functions. Our multimodal approach is innovative, and findings from this study has the potential to lead to the development of safe and effective rehabilitation protocols for older adults with impaired multisensory temporal integration and postural control.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
49mo left

Started Dec 2027

Longer than P75 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 2017

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 1, 2017

Completed
10.1 years until next milestone

Study Start

First participant enrolled

December 1, 2027

Expected
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2031

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

October 18, 2017

Last Update Submit

April 27, 2026

Conditions

Outcome Measures

Primary Outcomes (8)

  • Multisensory temporal processing performance change

    Change from pre-training performance

    At the end of 20-day training

  • Multisensory temporal processing performance change maintenance

    Change from pre-training performance

    30 days after training

  • Postural control and gait performance change

    Change from pre-training performance

    At the end of 20-day training

  • Postural control and gait performance change maintenance

    Change from pre-training performance

    30 days after training

  • Brain GABA level change

    Change from pre-training level

    At the end of 20-day training

  • Brain GABA level change maintenance

    Change from pre-training level

    30 days after training

  • Resting-state network segregation change

    Change from pre-training level

    At the end of 20-day training

  • Resting-state network segregation change maintenance

    Change from pre-training level

    30 days after training

Study Arms (2)

Inhibitory control training

EXPERIMENTAL

In the inhibitory control training condition, participants will be trained with tasks that involve both response withholding and rule switching. For example, participants will sort polygons based on features (e.g., shape or color) and will be asked to either provide or withhold sorting responses when presented with different cues. Rule-switching is introduced when participants must inhibit the "rule" used in the previous trial set and change the focus of their attention to a new sorting and/or inhibitory rule. Task difficulty will progressively increase over the course of training based on participants' abilities.

Behavioral: Inhibitory control training

knowledge-based training

SHAM COMPARATOR

The knowledge-based training condition serves as the control, in which participants will be presented with questions from different categories such as vocabulary, science, or geography and asked to select the correct answer from 4 alternatives within a certain time limit. Task difficulty will progressively increase over the course of training based on participants' abilities.

Behavioral: Knowledge-based training

Interventions

Cognitive training is inhibitory task-related.

Inhibitory control training

Training is not inhibitory task-related.

knowledge-based training

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 65 and 80 (elderly group) and between 20 and 35 (young group)

You may not qualify if:

  • History of epilepsy, stroke, Parkinson's disease, Alzheimer's disease, attention deficit-hyperactivity disorder
  • History of head injury with loss of consciousness, brain surgery, or psychiatric disorders
  • Early dementia or cognitive impairment
  • Serious vision problems (including best-corrected binocular visual acuity worse than 20/25)
  • Uncorrected hearing problems (pure tone threshold \> 40 dB for 1000-2000 Hz)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Fang Jiang, Ph.D

    University of Nevada, Reno

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fang Jiang, Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
50 elderly participants will be randomly assigned to one of the two training groups but will not be told whether they are in the inhibitory control (experiment) or knowledge-based (control) training group.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 50 elderly participants will be randomly assigned to one of the two training groups and will be asked to undergo 20 days of training (\~30 mins/day).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 18, 2017

First Posted

November 1, 2017

Study Start (Estimated)

December 1, 2027

Primary Completion (Estimated)

November 30, 2030

Study Completion (Estimated)

November 30, 2031

Last Updated

May 1, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

Results from proposed experiments will be reported either as group findings that do not identify individual participants, or by labeling the data of each participant with a unique code that does not include the participant's name or initials. De-identified individual participant data will be shared upon request and for research purpose only starting 1 year after publication.

Shared Documents
STUDY PROTOCOL, SAP, ANALYTIC CODE
Time Frame
Starting 1 year after publication
Access Criteria
Data will be shared upon request and for research purpose only.