Spatial Cognitive Training for Chronic Vestibular Disorders

In this study the investigators propose to apply cognitive training, which has been largely used in the realm of age-related cognitive decline, dementia, and Alzheimer's disease, in a novel clinical context to individuals with vestibular impairment. In prior work the investigators observed that individuals with vestibular loss have evidence of spatial cognitive impairment. The investigators plan to evaluate the preliminary efficacy and feasibility of a cognitive training program in a sample of participants with chronic vestibular impairment who display deficits in spatial ability. The cognitive training program will focus on visuospatial skills and will be used as an adjunct to traditional vestibular physical therapy (VPT).

Study Overview

• Status: Withdrawn
• Conditions: Cognitive Training; Vestibular Abnormality
• Intervention / Treatment: Behavioral: Spatial Cognitive Training

Detailed Description

Patients with chronic vestibular dysfunction with report symptoms of spatial cognitive impairment will be offered cognitive training. The intervention will consist of a well-validated cognitive training protocol that specifically targets spatial navigation skills. The protocol was developed by Willis et al. for the Adult Development and Enrichment Trial (ADEPT) trial, which trains map reading and route-learning skills through mental rotation training tasks over the course of 5 weeks. Patients will be assessed by study staff pre-intervention, immediately post-intervention and at 3 months post-intervention using spatial cognitive outcomes, quality of life measures, and gait and balance outcomes.

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of chronic vestibular disorder (>6months & diagnosis from laboratory testing by neuro-otologist)

Exclusion Criteria:

• Participants with dementia, or with blindness or deafness who cannot participate in cognitive training procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spatial Cognitive Training; map reading and route-learning skills	Behavioral: Spatial Cognitive Training; map reading and route-learning skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Dizziness Handicap Inventory	Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Dizziness Handicap Inventory	Subjective 25-item questionnaire measuring Quality of Life and disability on a scale from 0-100	Immediately post-training to 3 months post-training
Change from baseline in Dynamic Gait Index	Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Dynamic Gait Index	Balance challenges during 8 different gait tasks (head turns, speed changes, over/around obstacles) with total score out of 24 points.	Immediately post-training to 3 months post-training
Change from baseline in Four Square Step Test	Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Four Square Step Test	Assesses dynamic balance, spatial, & sequencing skills while stepping forward/back/sideways over a low obstacle (measured in seconds)	Immediately post-training to 3 months post-training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Money Road Map Test	Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Money Road Map Test	Assessment of egocentric mental rotation in space by recording total number of errors in right-left discrimination mental rotation tasks.	Immediately post-training to 3 months post-training
Change from baseline in Benton Visual Retention Test	visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Benton Visual Retention Test	visual perception and visual memory assessment by asking participant to reproduce 10 designs following a 10-second exposure and scored 0-10 based on correct drawing reconstruction.	Immediately post-training to 3 months post-training
Change from baseline in modified Clinical Test of Sensory Organization and Balance	Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in modified Clinical Test of Sensory Organization and Balance	Static standing balance during 4 conditions where sensory inputs are altered (eyes open/eyes closed on firm/foam surface) and each condition is timed for max of 30 seconds.	Immediately post-training to 3 months post-training
Change from baseline in Activities-specific Balance Confidence Scale	Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Activities-specific Balance Confidence Scale	Subjective questionnaire that determines confidence during daily tasks (scores range 0-100%)	Immediately post-training to 3 months post-training
Change from baseline in Santa Barbara Sense of Direction Scale	15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.	Baseline vs immediately post-training
Change from immediate post-training to 3-months post-training in Santa Barbara Sense of Direction Scale	15 question related to subjective sense of direction adeptness (ranging 1-7 for each item); cumulative score is divided by number of responses answered to yield a 1-7 total score.	Immediately post-training to 3 months post-training

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Brooke Klatt, PhD, PT, University of Pittsburgh

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 30, 2020
• Study Completion (Anticipated): August 31, 2020

Study Registration Dates

• First Submitted: May 11, 2019
• First Submitted That Met QC Criteria: May 11, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): September 10, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Labyrinth Diseases; Ear Diseases; Vestibular Diseases
• Other Study ID Numbers: STUDY19030436

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: dissemination of study findings in manuscript publication in scientific journal
• IPD Sharing Time Frame: 1 year
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No