Effect of Vestibular Perceptual Learning on Vestibular Thresholds and Balance

The Ohio State University

Status: Enrolling

Conditions: Healthy Aging

Treatments: Behavioral: Placebo Control; Behavioral: Roll Tilt Training; Behavioral: Translation Training; Behavioral: Both Tilt and Translation Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05818787

3R01AG073113-02S1 (U.S. NIH Grant/Contract)

R01AG073113

Details and patient eligibility

About

The intervention being studied is a minimal risk perceptual learning protocol delivered in an academic laboratory setting; the goal of the intervention is to improve the perception of passive whole-body tilts and/or translations, as well as balance, by providing feedback following passive tilts or translations of the body. The protocol lasts a total of ~45 days: Day 1 includes a pre-test assessment of perception and balance, as well as 100 repetitions of training, Days 2-7 each include 400 repetitions of training, and Day 6 includes only post-test assessments of perception and balance.

Full description

Three training paradigms will be evaluated in 3 cohorts of older 10 adults (N=30; Ages 65 to 89). Motion for all three training paradigms will be provided by a 12" Moog 6DoF motion platform. The first training protocol will be a roll tilt training protocol previously shown to reduce roll tilt thresholds. The second training protocols will be an inter-aural translation training protocol. The third training protocol will include half roll tilt training and half inter-aural translation training. As such, each cohort will perform perceptual training using a combination of the following training parameters:

1. Tilt Training: Training stimuli will be either a roll tilt to the left or right.
2. Translation Training: Training stimuli will be either a translation to the left or right.
3. Both Tilt Training and Translation Training will include half roll tilt training and half inter-aural translation training.
4. Older adults will train using a (A) 2-Down/1-Up (i.e., the size of the tilt stimulus decreases after 2 consecutive correct responses and increases after each incorrect response),
5. Feedback Method: During training, the accuracy of perceptual judgement (e.g., recognizing a left vs. right tilt motion) will be provided to the subject using a combination of auditory feedback and visual feedback. Auditory feedback will inform the subject whether they were correct or incorrect; visual feedback will be provided by the return motion with eyes open and lights on.

The targeted dates for each assessment and intervention period are shown, however, to permit greater adherence to the study protocol, tests of retention will be accepted if they occur within 7 to 10 days after the post-test (for the one-week follow-up) or 30 to 40 days after the post-test (for the one-month follow-up).

1. Intervention-First arm:

   1. Day 1: Pre-test assessment
   2. Days 2-7: Active perceptual learning intervention
   3. Day 8: Post-test assessment
   4. Day 15: One-week retention assessment
   5. Day 38: One-month retention assessment
   6. Days 39-44: Control intervention
   7. Day 45: Post-test assessment

2. Control-First arm:

   1. Day 1: Pre-test assessment
   2. Days 2-7: Control intervention
   3. Day 8: Post-test / Pre-Test assessment
   4. Days 9 to 14: Active perceptual learning intervention
   5. Day 15: Post-test assessment
   6. Day 22: One-week retention assessment
   7. Day 45: One-month retention assessment

Enrollment: 30 estimated patients

Sex: All

Ages: 65 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Must be able to stand
• No leg or foot amputations
• No lower limb braces
• Not currently feeling dizzy/lightheaded
• Not currently pregnant by self-report
• Weight <= 275 pounds

Exclusion criteria

• Severe head trauma or traumatic brain injury
• Any vestibular disorder (e.g., Meniere's Disease, Vestibular Migraine, Unresolved benign paroxysmal positional vertigo (BPPV), Vestibular hypofunction, except that due to aging, PPPD) as assessed by a Vestibular OtoNeurologist and Neurotologist using clinical diagnostic tests described in proposal plus any additional clinical evaluations they identify
• History of seizures
• Neurologic illness or condition determined by an Otoneurologist known to impact vestibular or balance function(e.g., stroke, neurodegenerative disorders, demyelinating illness)
• Major psychiatric (e.g., panic disorder, psychosis, etc.) disorder
• Any of the following eye diseases or conditions: amblyopia (or "lazy eye") or history of amblyopia, diagnosis of age-related macular degeneration, retina dystrophy, glaucoma, cataracts, or any other eye condition that limits vision to worse than 20/40
• Recent (<6 months) orthopedic injuries of the lower extremities (e.g., plantar fasciitis, ankle, knee or hip injury, back strain/herniated disc, …).
• Upper extremity injuries requiring current sling immobilization
• Recent surgery
• Any other severe health problem (heart disease, pulmonary disease, cancer, etc.).
• Vision in both eyes must be better than 20/40 with best correction
• Due to the potential for nausea with some of the motion stimuli, and to protect fetus and mother, pregnant women will also be excluded from this study
• Since every possible exclusionary factor cannot be predicted, additional exclusion criteria may be required

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 6 patient groups

Training Protocol 1 - Roll-Tilt Intervention First

Experimental group

Description:

Participants will complete a roll tilt training protocol previously shown to reduce roll tilt thresholds. The training stimulus parameters are as follows: stimulus size for 0.5 Hz roll tilt motion will be adjusted based upon subject responses using a 2-down, 1-up (2D/1U) staircase, and both auditory and visual feedback will be provided.The training protocol will be completed first, followed by the placebo intervention.

Treatment:

Behavioral: Roll Tilt Training

Behavioral: Placebo Control

Training Protocol 1 - Placebo First

Experimental group

Description:

Participants will complete a roll tilt training protocol previously shown to reduce roll tilt thresholds. The training stimulus parameters are as follows: 0.5 Hz roll tilt motion, stimulus size will be adjusted based upon subject responses using a 2D/1U staircase, and both auditory and visual feedback will be provided. The placebo intervention will be completed first, followed by the roll tilt training intervention.

Treatment:

Behavioral: Roll Tilt Training

Behavioral: Placebo Control

Training Protocol 2 - Y-Translation Intervention First

Experimental group

Description:

Participants will complete an inter-aural translation training protocol. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion, stimulus size will be adjusted based upon subject responses using a 2-down, 1-up (2D/1U) staircase, and both auditory and visual feedback will be provided.The training protocol will be completed first, followed by the placebo intervention.

Treatment:

Behavioral: Translation Training

Behavioral: Placebo Control

Training Protocol 2 - Placebo First

Experimental group

Description:

Participants will complete an inter-aural training protocol. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion, stimulus size will be adjusted based upon subject responses using a 2D/1U staircase, and auditory and visual feedback will be provided. The placebo intervention will be completed first, followed by the training intervention.

Treatment:

Behavioral: Translation Training

Behavioral: Placebo Control

Training Protocol 3 - Mixed Intervention First

Experimental group

Description:

Participants will complete a training protocol that includes half roll tilt and half inter-aural translation. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion and 0.5Hz roll tilt, stimulus size will be adjusted based upon subject responses using 2-down, 1-up (2D/1U) staircases, and both auditory and visual feedback will be provided. The training protocol will be completed first, followed by the placebo intervention.

Treatment:

Behavioral: Both Tilt and Translation Training

Behavioral: Placebo Control

Training Protocol 3 - Placebo First

Experimental group

Description:

Participants will complete a training protocol that includes half roll tilt and half inter-aural translation. The training stimulus parameters are as follows: 0.5 Hz inter-aural translation motion and 0.5 Hz roll tilt, stimulus size will be adjusted based upon subject responses using 2D/1U staircases, and auditory and visual feedback will be provided. The placebo intervention will be completed first, followed by the training intervention.

Treatment:

Behavioral: Both Tilt and Translation Training

Behavioral: Placebo Control