- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03328455
The Role of GABA-mediated Inhibition in Multisensory Temporal Processing & Postural Control in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The investigators will examine the effects of cognitive training in the elderly on multisensory temporal processing and postural control. The investigators will include 25 young participants and use their performance to establish age-related differences and target performance for training in the elderly. 50 elderly participants will be randomly assigned to one of the two training groups and will be asked to undergo 20 days (~30 mins/day) of inhibitory control training or knowledge-based training. Multisensory temporal processing abilities, postural stability and gait performance, brain GABA concentration, and resting-state based network segregation will be assessed before and immediately after training. Follow-up assessments will be carried out 30 days after training to examine the persistence of training effects.
Stimulus presentation. Visual and auditory stimuli will be generated using MATLAB and the psychophysics toolbox. Visual and auditory stimuli will be delivered via Display++ system and an AudioFile stimulus processor, respectively (Cambridge Research Systems). The use of these two devices allows for precise control of stimulus timing.
Inhibitory control training. Participants will be trained with tasks that involve both response withholding and rule switching. For example, participants will be asked to 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.
Knowledge-based training. This condition serves as the control. 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.
In both training conditions, task difficulty will progressively increase over the course of training based on participants' abilities. Pre- and post-training assessment of multisensory temporal processing abilities, postural stability and gait performance, brain GABA concentration, and resting-state based network segregation will be conducted.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Fang Jiang, Ph.D
- Phone Number: 775-682-8606
- Email: fangj@unr.edu
Study Locations
-
-
Nevada
-
Reno, Nevada, United States, 89557
- University of Nevada, Reno
-
Contact:
- Fang Jiang, Ph.D
- Phone Number: 775-682-8606
- Email: fangj@unr.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 65 and 80 (elderly group) and between 20 and 35 (young group)
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Inhibitory control training
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.
|
Cognitive training is inhibitory task-related.
|
Sham Comparator: knowledge-based training
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.
|
Training is not inhibitory task-related.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Multisensory temporal processing performance change
Time Frame: At the end of 20-day training
|
Change from pre-training performance
|
At the end of 20-day training
|
Multisensory temporal processing performance change maintenance
Time Frame: 30 days after training
|
Change from pre-training performance
|
30 days after training
|
Postural control and gait performance change
Time Frame: At the end of 20-day training
|
Change from pre-training performance
|
At the end of 20-day training
|
Postural control and gait performance change maintenance
Time Frame: 30 days after training
|
Change from pre-training performance
|
30 days after training
|
Brain GABA level change
Time Frame: At the end of 20-day training
|
Change from pre-training level
|
At the end of 20-day training
|
Brain GABA level change maintenance
Time Frame: 30 days after training
|
Change from pre-training level
|
30 days after training
|
Resting-state network segregation change
Time Frame: At the end of 20-day training
|
Change from pre-training level
|
At the end of 20-day training
|
Resting-state network segregation change maintenance
Time Frame: 30 days after training
|
Change from pre-training level
|
30 days after training
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Fang Jiang, Ph.D, University of Nevada, Reno
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1086690
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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