StrokeReTrieveNCT05740553
Automated Stereognosis to Treat Loss of Tactile Function After Brain Injury
A study testing ReTrieve Automated Stereognosis System in people with Stroke and Chronic Brain Injury, run by The University of Texas at Dallas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Chronic Brain Injury, Peripheral Neuropathy
- What is being tested?
- ReTrieve Automated Stereognosis System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2021to 6 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Significant cognitive deficits that would preclude them from understanding instructions
- Significant communication deficits that would preclude them from consenting for themselves
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas at Dallas
Richardson, Texas, 75080
About this study
Official title: 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.
Read the 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.
- Conditions
- Stroke, Chronic Brain Injury, Peripheral Neuropathy
- Being tested
- ReTrieve Automated Stereognosis System
- Medical subject headings
- Stroke, Brain Injury, Chronic, Peripheral Nervous System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReTrieve Automated Stereognosis SystemDevice
An automated tactile training system that may help patients recover lost tactile function after brain injury.
| Study group | Role | What they receive |
|---|---|---|
| Training First | Experimental | Not described Receives: Device: ReTrieve Automated Stereognosis System |
| Training Second | Experimental | Not described Receives: Device: ReTrieve Automated Stereognosis System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Retrievals
The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use
Measured: 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
Measured: 6-8 weeks
Secondary outcomes (2)
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.
Measured: 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.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start15 Nov 2021
- Primary completion6 Jun 2022
- Study completion6 Jun 2022
Why it stopped: Inadequate participant recruitment (potentially due to COVID-19)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740553
- Sponsor's protocol ID
- 21-12
- Acronym
- ReTrieve
- Status last verified
- Jan 2023
- First submitted
- 13 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using the ReTrieve Automated Stereognosis System to Treat Loss of Tactile Function After Brain Injury
- ClinicalTrials.gov ID
- NCT05740553
- Acronym / sponsor ID
- ReTrieve / 21-12
- Conditions
- Stroke, Chronic Brain Injury, Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate participant recruitment (potentially due to COVID-19)
- Enrolment
- 3 participants (actual)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 6 Jun 2022 (actual)
- Study completion
- 6 Jun 2022 (actual)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Training First | Experimental | Device: ReTrieve Automated Stereognosis System |
| Training Second | Experimental | Device: ReTrieve Automated Stereognosis System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (2 listed)
- Significant cognitive deficits that would preclude them from understanding instructions
- Significant communication deficits that would preclude them from consenting for themselves
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReTrieve Automated Stereognosis SystemAn automated tactile training system that may help patients recover lost tactile function after brain injury. | Device | Training First, Training Second |
Primary outcome
Number of Retrievals
Time frame: 6-8 weeks
The majority of participants should manage at least 4500 retrievals over their ~30 hours of system use
Number of Retrievals per Hour
Time frame: 6-8 weeks
The majority of participants should achieve at least 700 retrievals per hour by the end of training
2 secondary outcomes
Improved Tactile Function
Time frame: 6-8 weeks
Improved Perceived Tactile Function
Time frame: 6-8 weeks
Results and safety
The study was stopped early (reason given: Inadequate participant recruitment (potentially due to COVID-19)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ReTrieve Automated Stereognosis System in people with Stroke and Chronic Brain Injury, run by The University of Texas at Dallas at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Inadequate participant recruitment (potentially due to COVID-19)). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Retrievals (time frame: 6-8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.