Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury

NCT05740553 | Terminated

• 1 other identifier: 21-12
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stroke; Chronic Brain Injury; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Improved Tactile Function

  6-8 weeks

• Improved Perceived Tactile Function

  6-8 weeks

Study Arms (2)

Training First

EXPERIMENTAL

Device: ReTrieve Automated Stereognosis System

Training Second

EXPERIMENTAL

Device: ReTrieve Automated Stereognosis System

Interventions

ReTrieve Automated Stereognosis System DEVICE

An automated tactile training system that may help patients recover lost tactile function after brain injury.

Training First; Training Second

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The University of Texas at Dallas: lead

Study Sites (1)

University of Texas at Dallas

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Stroke; Brain Injury, Chronic; Peripheral Nervous System Diseases

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Damage, Chronic; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries; Neuromuscular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants complete tactile training for 6-8 weeks, and complete no additional training for 8 weeks. One group will begin with tactile training, and the other group will begin with no additional training, then they will swap. At each time point (before portion 1, after portion 1, and after portion 2) their tactile function will be assessed.

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: February 23, 2023
• Study Start: November 15, 2021
• Primary Completion: June 6, 2022
• Study Completion: June 6, 2022
• Last Updated: March 6, 2023

Record last verified: 2023-01

Locations

US (1)