NCT04810442

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

March 23, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

March 23, 2021

Status Verified

March 1, 2021

Enrollment Period

2.1 years

First QC Date

December 5, 2019

Last Update Submit

March 18, 2021

Conditions

Keywords

functional MRIMotor LearningNapSleep BenefitsTraumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

  • Tapping Task Performance Gain

    The number of correct tapping sequences across 30sec time intervals for the learning trials and post-intervention retest trials will be calculated for each participant. Tapping Task Performance Gain will be operationally defined as the mean of correct sequences within the final block of learning trials subtracted from the mean of correct sequences within the first block of retest trials. Analysis of Covariance will be performed with Tapping Task Performance Gain as the independent variable and treatment group (Nap vs. Rest) as the dependent variable. Covariates of age and learning capacity (calculated as the difference between the mean of correct sequences in the initial and final blocks of the learning trials) will be entered into the model.

    through study completion, an average of 2 years

  • Bold Signal Change

    Beta weights associated with the Nap and Rest Groups.

    through study completion, an average of 2 years

  • Number of Sleep Spindles

    The number of sleep spindles in the EEG output generated by the Sleep Profiler within the 45-minute nap will be counted. Pearson correlations will be used to examine the relationship between performance gains and the number of sleep spindles within the Nap group.

    through study completion, an average of 2 years

Study Arms (2)

Nap Group

EXPERIMENTAL

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

Other: Nap

No-Nap Group

NO INTERVENTION

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

NapOTHER

45-minute nap between scanning procedures

Nap Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

East Hanover, New Jersey, 07936, United States

RECRUITING

Related Publications (15)

  • Kleim JA. Neural plasticity and neurorehabilitation: teaching the new brain old tricks. J Commun Disord. 2011 Sep-Oct;44(5):521-8. doi: 10.1016/j.jcomdis.2011.04.006. Epub 2011 Apr 30.

    PMID: 21600589BACKGROUND
  • Krakauer JW. Motor learning: its relevance to stroke recovery and neurorehabilitation. Curr Opin Neurol. 2006 Feb;19(1):84-90. doi: 10.1097/01.wco.0000200544.29915.cc.

    PMID: 16415682BACKGROUND
  • Nudo RJ. Neural bases of recovery after brain injury. J Commun Disord. 2011 Sep-Oct;44(5):515-20. doi: 10.1016/j.jcomdis.2011.04.004. Epub 2011 Apr 30.

    PMID: 21600588BACKGROUND
  • Smith C, MacNeill C. Impaired motor memory for a pursuit rotor task following Stage 2 sleep loss in college students. J Sleep Res. 1994 Dec;3(4):206-213. doi: 10.1111/j.1365-2869.1994.tb00133.x.

    PMID: 10607127BACKGROUND
  • Walker MP, Brakefield T, Morgan A, Hobson JA, Stickgold R. Practice with sleep makes perfect: sleep-dependent motor skill learning. Neuron. 2002 Jul 3;35(1):205-11. doi: 10.1016/s0896-6273(02)00746-8.

    PMID: 12123620BACKGROUND
  • Walker MP, Stickgold R, Alsop D, Gaab N, Schlaug G. Sleep-dependent motor memory plasticity in the human brain. Neuroscience. 2005;133(4):911-7. doi: 10.1016/j.neuroscience.2005.04.007.

    PMID: 15964485BACKGROUND
  • Walker MP. Sleep-dependent memory processing. Harv Rev Psychiatry. 2008;16(5):287-98. doi: 10.1080/10673220802432517.

    PMID: 18803104BACKGROUND
  • Walker MP, Stickgold R. Sleep, memory, and plasticity. Annu Rev Psychol. 2006;57:139-66. doi: 10.1146/annurev.psych.56.091103.070307.

    PMID: 16318592BACKGROUND
  • Milner CE, Fogel SM, Cote KA. Habitual napping moderates motor performance improvements following a short daytime nap. Biol Psychol. 2006 Aug;73(2):141-56. doi: 10.1016/j.biopsycho.2006.01.015. Epub 2006 Mar 15.

    PMID: 16540232BACKGROUND
  • Korman M, Doyon J, Doljansky J, Carrier J, Dagan Y, Karni A. Daytime sleep condenses the time course of motor memory consolidation. Nat Neurosci. 2007 Sep;10(9):1206-13. doi: 10.1038/nn1959. Epub 2007 Aug 12.

    PMID: 17694051BACKGROUND
  • Siengsukon CF, Boyd LA. Sleep enhances implicit motor skill learning in individuals poststroke. Top Stroke Rehabil. 2008 Jan-Feb;15(1):1-12. doi: 10.1310/tsr1501-1.

    PMID: 18250068BACKGROUND
  • Nishida M, Walker MP. Daytime naps, motor memory consolidation and regionally specific sleep spindles. PLoS One. 2007 Apr 4;2(4):e341. doi: 10.1371/journal.pone.0000341.

    PMID: 17406665BACKGROUND
  • Backhaus J, Junghanns K. Daytime naps improve procedural motor memory. Sleep Med. 2006 Sep;7(6):508-12. doi: 10.1016/j.sleep.2006.04.002. Epub 2006 Aug 23.

    PMID: 16931152BACKGROUND
  • Debas K, Carrier J, Orban P, Barakat M, Lungu O, Vandewalle G, Hadj Tahar A, Bellec P, Karni A, Ungerleider LG, Benali H, Doyon J. Brain plasticity related to the consolidation of motor sequence learning and motor adaptation. Proc Natl Acad Sci U S A. 2010 Oct 12;107(41):17839-44. doi: 10.1073/pnas.1013176107. Epub 2010 Sep 27.

    PMID: 20876115BACKGROUND
  • Fogel S, Albouy G, King BR, Lungu O, Vien C, Bore A, Pinsard B, Benali H, Carrier J, Doyon J. Reactivation or transformation? Motor memory consolidation associated with cerebral activation time-locked to sleep spindles. PLoS One. 2017 Apr 19;12(4):e0174755. doi: 10.1371/journal.pone.0174755. eCollection 2017.

    PMID: 28422976BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Anthony Lequerica, Ph.D.

    Kessler Foundation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2019

First Posted

March 23, 2021

Study Start

February 18, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

March 23, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations