Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury (ReTrieve)

Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury

Researchers aim to determine whether the ReTrieve system for tactile training can improve tactile function (sense of touch) in the hand after brain injury when used at home for 6 weeks.

Study Overview

• Status: Terminated
• Conditions: Stroke; Peripheral Neuropathy; Chronic Brain Injury
• Intervention / Treatment: Device: ReTrieve Automated Stereognosis System

Detailed Description

All participants who have been found eligible for this study and given informed consent will be randomized into two groups- either participants will begin ReTrieve training immediately following an initial assessment, or wait 8 weeks before beginning training.

During the study, participants will have a ReTrieve tactile training system delivered home for use over 6 weeks. Investigators will take three days to teach participants how to use the system. Each week for the remainder of the 6 weeks, participants will use this system for 4+ days per week on their own, and for 1 day supervised. During each supervised day, participants will complete approximately 1 hour of training while supervised over video chat with researchers.

Participants' tactile function will be assessed at three separate time points: once within one week before beginning training, once within one week after completing training, as well as once either 8 weeks before or 8 weeks after the training. This assessment has a required survey component, as well as an optional in-person clinical assessment component.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Richardson, Texas, United States, 75080
      • University of Texas at Dallas

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:

• English speaking
• Be able to communicate and consent for themselves
• Have experienced a brain injury more than 6 months prior to the date of study participation
• Have chronic tactile deficits in at least one hand as a result of their brain injury
• Have sufficient motor ability in their affected hand(s) to complete reach and grasp tasks
• Have sufficient motor ability in their affected hand(s) to raise their arms above their head
• Have sufficient motor ability in their affected hand(s) to hold objects
• Have wireless internet and a laptop or mobile device at home for video conferencing
• Live in the greater Dallas area

Exclusion Criteria:

• Significant cognitive deficits that would preclude them from understanding instructions
• Significant communication deficits that would preclude them from consenting for themselves

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Training First	Device: ReTrieve Automated Stereognosis System; An automated tactile training system that may help patients recover lost tactile function after brain injury.
Experimental: Training Second	Device: ReTrieve Automated Stereognosis System; An automated tactile training system that may help patients recover lost tactile function after brain injury.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Retrievals	The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use	6-8 weeks
Number of Retrievals per Hour	The majority of participants should achieve at least 700 retrievals per hour by the end of training	6-8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Tactile Function	Participants should show a significantly greater increase in tactile function as measured by the French variation of the Upper Extremity subscore of the Erasmus modified Nottingham Sensory Assessment [High scores are better. Assessment performed for both hands. Scores range from 0-48 (0-24 per hand) on somesthesia, and 0-20 (0-10) on stereognosis. Total score range per participant is 0-68 (0-34 per hand)] when measured over their 6-8 weeks of tactile training than when measured over their 8 weeks without tactile training.	6-8 weeks
Improved Perceived Tactile Function	Participants should show a significantly greater increase in their perceived tactile function score as measured by the 'ABILHAND' questionnaire [High scores are better. Answered for only most impaired hand. 23 activities scored 0(impossible)-2(easy) Score range 0-46] combined with a modified version of the Sensory Perception Quotient (modified to focus on tactile and remove temperature) [High scores are better. Score range 0-18. Answered for only most impaired hand.] when measured over their 6-8 weeks of tactile training than when measured over their 8 weeks without tactile training.	6-8 weeks

Collaborators and Investigators

• Sponsor: The University of Texas at Dallas

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): June 6, 2022
• Study Completion (Actual): June 6, 2022

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 23, 2023

Study Record Updates

• Last Update Posted (Estimate): March 6, 2023
• Last Update Submitted That Met QC Criteria: March 2, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Neuromuscular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Peripheral Nervous System Diseases; Wounds and Injuries; Brain Injury, Chronic
• Other Study ID Numbers: 21-12

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

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