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Neurotraining for Concussion

Q: Is this research still open to participants?

Information hosted on clinicaltrials.gov indicates that this particular trial is not recruiting at present, having been initially published in July 1st of 2023 and last revised on the 15th of July 2022. Nevertheless, there are 923 other medical trials enrolling patients presently.

Q: What type of participant would be most suitable for this research project?

This clinical study is seeking 80 participants, aged 18 to 55 years old, who have sustained a mild <a href="https://www.withpower.com/clinical-trials/traumatic-brain-injury">traumatic brain injury</a> (mTBI). To qualify for the experiment, they must also exhibit signs of post-traumatic amnesia up to 24 hours after their accident; display confusion or disorientation during and shortly thereafter; experience some memory loss regarding events that occurred before and directly after the incident; possess a Glasgow Coma Scale score between 13-15 (anything below denoting a more severe <a href="https://www.withpower.com/clinical-trials/tbi">TBI</a>); demonstrate focal neurological deficits which may be short-lived; present with one or multiple concussions as diagnosed by medical professionals at time of examination

Q: What is the goal of this experiment?

The objective of this medical trial is to measure any improvements in Visual Working Memory. To check this, 12 weeks of PATH, Sham, and N-Back WM training will be administered before and after the study period. Secondary outcomes monitored include Change in ACC Function (measured using time-locked signals during a working memory N-back task), Change in Auditory Working Memory (evaluated through Digit Span subtest &#x26; Letter Number Sequencing Subtest) and Change in Attention (examined by Color Word Interference Test Standardized Percentile Rank for Inhibition).

Q: Is enrollment open for participants under the age of 40 in this clinical trial?

The parameters for this research require that the participants are between 18 and 55 years old. There is an abundance of trials available to those under 18 (169) or over 65 (708).

N/A

Recruiting

Led By Teri Lawton, Ph.D.

Research Sponsored by Perception Dynamics Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Aged between 18 to 60 years

Diagnosis of mTBI (scoring between 19-25 on MoCA screening test)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up immediately after 12 weeks of intervention training

Awards & highlights

Study Summary

This trial will test a new neurotraining program to improve working memory and attention in people with concussions. If it is effective, it could provide a new way to help people with concussions recover.

Who is the study for?

This trial is for individuals aged 18-60 who have had a mild traumatic brain injury (mTBI) and score between 19-25 on the MoCA test. Participants must read English, have corrected 20/20 vision, and be able to commit time to complete the study. Those with post-traumatic amnesia over 24 hours, recent mTBI (<3 months), or certain cognitive impairments are excluded.Check my eligibility

What is being tested?

The study tests PATH neurotraining's ability to improve working memory and attention in patients with mTBI. It aims to establish if this training can rapidly and effectively remediate cognitive issues caused by concussions.See study design

What are the potential side effects?

Since this trial involves cognitive training exercises rather than medication, traditional side effects are not expected. However, participants may experience fatigue or frustration during the tasks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 60 years old.

Select...

I have a mild traumatic brain injury, as shown by my MoCA test score of 19-25.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ immediately before and after 12 weeks of path, sham, and n-back wm training.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~immediately before and after 12 weeks of path, sham, and n-back wm training.

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately before and after 12 weeks of path, sham, and n-back wm training. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Processing Speed

Change in Visual Working Memory

Secondary outcome measures

Change in ACC Function

Change in Attentional Focus

Change in Auditory Working Memory

+10 more

Other outcome measures

Blinding Assessments

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: PATH neurotrainingExperimental Treatment1 Intervention

Subject looks at computer screen to determine whether dim gray stripes in fish-shaped window move left or right relative to stationary background stripes. The subject reports which way center stripes move by pushing left or right arrow key, receiving brief tone if incorrect. Program adaptively changes contrast of test pattern in order to keep subject at 79% correct. There are levels of difficulty introduced by making the background pattern more similar to that in fish, by increasing pattern's complexity level, and by increasing number of directions of movement from one to two directions of motion. Intervention will be trained for one training cycle, 15 minutes, 3 times each week for 16 weeks. Fifteen minutes of working memory practice, recalling the correct sequence of digits, each presented for 500 msec, from 5 digits up to 10 digits will be completed for 15 minutes following PATH training.

Group II: N-Back Working Memory TaskExperimental Treatment1 Intervention

Participants are required to compare each item on a computer screen to the item that they saw n-items back in the sequence. The participant plays a simple game where they control the movement of an astronaut that needs to collect correct gems, avoid incorrect gems, and also obstacles, to succeed at the game. If the participants performs well then they can be advanced to the 2-back, 3-back, 4-back, etc where they make similar matches but to earlier items in the sequence. This gamified task consists of a color n-back with 6 colors (a new color every 3 seconds, requiring subjects respond to targets by tapping the screen and navigating the astronaut to the targets, and avoiding the distractors) with 30% targets, and where the n-level will change every 2 minutes depending on performance (increase if performance is >85% and decrease if <75%). Sessions consist of 10 ~2 minute blocks, each with n-level as determined by the adaptive procedure and with user paced breaks between blocks.

Group III: Orientation Discrimination trainingPlacebo Group1 Intervention

The sham intervention will be Orientation Discrimination training that is identical to PATH training except instead of low contrast sinewave gratings moving left or right, 100% contrast stationary test and background sinewave gratings are used, both red, green, and black and white gratings, see patterns in Fig. 4 below. These patterns are randomly oriented left or right, at decreasing tilt angles as the test grating's orientation is identified correctly. These patterns only activate parvocells in ventral pathways (Ungerleider & Mishkin, 1982; Kaplan & Shapley, 1986) instead of activating dorsal pathways, the key component of PATH neurotraining. Therefore, this task does not speed up the brain's visual timing, which is a function of the dorsal stream. For the Orientation Discrimination task, the subject pushes the left arrow key when the test pattern is tilted left and the right arrow key when pattern is tilted right. Otherwise the two training tasks use the same paradigm.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of South AlabamaOTHER

42 Previous Clinical Trials

15,854 Total Patients Enrolled

Perception Dynamics InstituteLead Sponsor

1 Previous Clinical Trials

University of California, San DiegoOTHER

1,126 Previous Clinical Trials

1,552,911 Total Patients Enrolled

Media Library

PATH neurotraining Clinical Trial Eligibility Overview. Trial Name: NCT03655782 — N/A

PATH neurotraining 2023 Treatment Timeline for Medical Study. Trial Name: NCT03655782 — N/A

Concussion Research Study Groups: PATH neurotraining, N-Back Working Memory Task, Orientation Discrimination training

Concussion Clinical Trial 2023: PATH neurotraining Highlights & Side Effects. Trial Name: NCT03655782 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research still open to participants?

"Information hosted on clinicaltrials.gov indicates that this particular trial is not recruiting at present, having been initially published in July 1st of 2023 and last revised on the 15th of July 2022. Nevertheless, there are 923 other medical trials enrolling patients presently."

Answered by AI

What type of participant would be most suitable for this research project?

"This clinical study is seeking 80 participants, aged 18 to 55 years old, who have sustained a mild traumatic brain injury (mTBI). To qualify for the experiment, they must also exhibit signs of post-traumatic amnesia up to 24 hours after their accident; display confusion or disorientation during and shortly thereafter; experience some memory loss regarding events that occurred before and directly after the incident; possess a Glasgow Coma Scale score between 13-15 (anything below denoting a more severe TBI); demonstrate focal neurological deficits which may be short-lived; present with one or multiple concussions as diagnosed by medical professionals at time of examination"

Answered by AI

What is the goal of this experiment?

"The objective of this medical trial is to measure any improvements in Visual Working Memory. To check this, 12 weeks of PATH, Sham, and N-Back WM training will be administered before and after the study period. Secondary outcomes monitored include Change in ACC Function (measured using time-locked signals during a working memory N-back task), Change in Auditory Working Memory (evaluated through Digit Span subtest & Letter Number Sequencing Subtest) and Change in Attention (examined by Color Word Interference Test Standardized Percentile Rank for Inhibition)."

Answered by AI

Is enrollment open for participants under the age of 40 in this clinical trial?

"The parameters for this research require that the participants are between 18 and 55 years old. There is an abundance of trials available to those under 18 (169) or over 65 (708)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury

2023. "Retraining Neural Pathways Improves Cognitive Skills After A Mild Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03655782.

All > Concussion > Traumatic Brain Injury