Recruiting

Motor Skill Learning

Sponsor:

Kessler Foundation

Code:

NCT04810442

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Nap

Study Details

Brief summary:

Studies have shown that a period of sleep, even in the form of a daytime nap, after a period of training on a motor learning task can boost subsequent performance beyond that observed after an equal amount of time spent awake and resting. This leap in performance has been referred to as "off-line" motor learning because it occurs during a period of sleep in the absence of additional practice. Motor learning is an integral part of the physical and occupational therapy that patients receive after traumatic brain injury (TBI) in which various activities of daily living may need to be relearned. Targeted motor skills may include dressing (learning how to zip up a jacket or button a shirt), using a fork and knife to eat, or using technology (tapping touch screen on a cell phone or typing on a computer). Yet the potential of sleep in the form of a strategic nap as a therapeutic tool to maximize motor learning in rehabilitation therapies has not been fully realized. In addition, a growing body of research among healthy individuals has shown evidence of changes in the brain associated with enhanced performance among those who slept following training compared with those who spent the same amount of time awake. The neural mechanisms of "off-line" motor learning have not been studied among individuals with TBI. Using functional neuroimaging and measurement of brain waves, the current study will examine the mechanisms underlying this sleep-related enhancement of motor learning among individuals with TBI and determine how brain physiology may influence the magnitude of the effect. By understanding how this treatment works and identifying the factors that modulate its effectiveness we can identify which individuals will be most likely to benefit from a nap after training to improve motor learning after TBI. This can provide a more person-centered approach to treatment delivery that can maximize the effectiveness of a simple but potent behavioral intervention.

Conditions

Traumatic Brain Injury

Study ID

NCT04810442

Start date

Feb 18, 2020

Status verified date

Mar, 2021

Completion date

Mar 31, 2022

Anticipated

Primary completion date

Mar 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • I am between the ages of 18-65
  • I have a diagnosis of a moderate to severe Traumatic Brain Injury
  • I am at least 1 year post-injury
  • I am a habitual napper (I nap at least once per week) or I am able to fall asleep in a comfortable reclining chair in a dimly lit room
  • I am right handed
  • I can read and speak English fluently

Exclusion Criteria:

  • I am pregnant
  • I have had a prior stroke or neurological disease
  • I have a history of significant psychiatric illness
  • I am unable to demonstrate fine motor movements by touching each of my fingers to my thumb on the same hand
  • I am taking dopaminergic medication.
  • I have a significant alcohol or drug abuse history
  • My vision is impaired - more than 20/60 in worst eye
  • I have previous experience in playing a musical instrument
  • I have been told by my doctor that it is unsafe for me to receive regular MRI
  • I have non-titanium metal in my body or something in my body in which will keep me from being still in the MRI
  • I have a movement disorder in which will keep me from being still in the MRI

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Nap Group

This group will be involved with taking a nap in between the two scanning procedures.

no intervention: No-Nap Group

This group will not be taking a nap in between the two scanning procedures, and instead will be silently watching a film for the 45 minute period.

Interventions

Nap

45-minute nap between scanning procedures

Primary outcome measure

  • Tapping Task Performance Gain [ Time Frame: through study completion, an average of 2 years ]
  • Bold Signal Change [ Time Frame: through study completion, an average of 2 years ]
  • Number of Sleep Spindles [ Time Frame: through study completion, an average of 2 years ]

Central Contacts and Locations

Central contacts

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

Contacts

Principal Investigator:

Anthony Lequerica, Ph.D.

More Information

Sponsor

Kessler Foundation

Last update posted

Mar 23, 2021

Last verified

Mar, 2021

Keywords

  • functional MRI
  • Motor Learning
  • Nap
  • Sleep Benefits
  • Traumatic Brain Injury

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2021-03-23.