Traumatic Brain InjuryNCT04810442
Investigating How Sleep After Training Can Affect the Learning of a Motor Skill in Individuals With Brain Injury
A study testing Nap in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Nap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 31 Mar 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Kessler Foundation
East Hanover, New Jersey, 07936
Anthony Lequerica, Ph.D., 973-324-8454, alequerica@kesslerfoundation.org
Angela Spirou, M.A., 973-324-8394, aspirou@kesslerfoundation.org
About this study
Official title: Investigation of Neural Mechanisms Associated With Sleep-Dependent Enhancement of Motor Learning After Brain Injury
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.
Read the detailed description
Procedural memory is vitally important to the efficacy of rehabilitation following Traumatic Brain Injury (TBI). Specifically, during rehabilitation, persons with TBI must re-learn many motor skills associated with activities of daily living to improve functional outcomes. Emerging research on neuroplasticity after brain damage is beginning to increase our understanding of motor learning principles and how they interact with the training that takes place in neurorehabilitation.
There is a strong body of evidence showing the importance of sleep in procedural learning among healthy individuals. Within this body of research on sleep and procedural learning, there is substantial evidence demonstrating sleep-dependent neuroplasticity. Participants trained on a motor learning task show improvements over the training period, as expected. However, when re-tested after a period of sleep, performance is significantly better than when retested after an equivalent period of time awake. The actual enhancement of a learned motor skill in the absence of additional practice trials suggests that one can decrease the time necessary for learning a motor skill by incorporating a daytime nap after a period of training. The implications of these findings can be ground-breaking when applied to brain injury rehabilitation where motor learning may be a major focus of physical and occupational therapies. There is evidence of a positive impact of sleep on procedural memory and rehabilitation progress among older individuals after stroke, and the investigators have pilot data showing a substantial positive effect of a post-training nap on motor learning in an acquired brain injury sample. However, the neural mechanisms involved in this process after traumatic brain injury are less understood.
Among healthy individuals, there are numerous studies examining neural biomarkers that can quantify the effect of sleep on motor learning. Studies have reported that changes in sleep physiology and neural activation after training correlate with the degree of improvement at post-intervention testing. Studies showed that, after a nap of 60-90 minutes, speed of performance was enhanced, and the degree of enhancement was associated with the duration of stage 2 non-rapid eye movement (NREM) sleep. This relationship with stage 2 NREM sleep has also been shown after a 20-minute nap. In addition, changes in neural activation in the striatum have been found to be more pronounced when individuals slept after training than when they remained awake. In another study in which a night of sleep occurred between training and retest, changes in striatal activity were correlated with performance gains on the motor learning task. This study also showed evidence of EEG changes during sleep after the training period in the amount of sleep-spindle activity, a waveform associated with stage 2 NREM sleep.
While our preliminary findings show evidence of off-line motor learning after a nap among individuals with acquired brain injury, research into the mechanisms of action driving this response among individuals with TBI is lacking. A better understanding of neurophysiology and its influence on the magnitude of the effect is a crucial step in determining which individuals would be likely to benefit from this behavioral intervention.
Specific Aim 1-Behavioral Intervention: In a sample of individuals with TBI living in the community, demonstrate greater improvement on a motor sequence learning task after a daytime nap compared with an equivalent time spent awake and resting. This aim will also explore the individual differences in terms of demographics and injury characteristics contributing to the magnitude of the effect.
Hypothesis 1. Individuals exposed to a nap after a period of training on the motor sequence learning task will demonstrate greater improvement in speed and accuracy from the end of training to the post-nap retesting.
Research Question 1. How does the magnitude of the effect correlate with demographic factors and injury characteristics? Specific Aim 2-Functional Neuroimaging: To examine the neural correlates of off-line motor learning among individuals with TBI who were given a nap after training on the motor sequence learning task using functional MRI compared with a control group who received an equivalent period of time awake.
Hypothesis 2. Individuals in the nap group will show more pronounced changes in activation within the striatum and motor cortex compared with those who remained awake and resting.
Specific Aim 3-Sleep Physiology: To examine aspects of stage 2 sleep associated with performance gains (duration of stage 2 and degree of spindle activity) occurring during the nap period after training.
Hypothesis 3a. Among participants in the nap group, there will be a significant positive correlation between the degree of improvement and the duration of stage 2 sleep.
Hypothesis 3b. Among participants in the nap group, there will be a significant positive correlation between the degree of improvement and density of sleep spindles.
- Conditions
- Traumatic Brain Injury
- Being tested
- Nap
- Keywords
- functional MRI, Motor Learning, Nap, Sleep Benefits, Traumatic Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NapOther
45-minute nap between scanning procedures
| Study group | Role | What they receive |
|---|---|---|
| Nap Group | Experimental | This group will be involved with taking a nap in between the two scanning procedures. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 years
Bold Signal Change
Beta weights associated with the Nap and Rest Groups.
Measured: 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.
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start18 Feb 2020
- Primary completion31 Mar 2022 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anthony Lequerica, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04810442
- Sponsor's protocol ID
- R-1061-19
- Status last verified
- Mar 2021
- First submitted
- 5 Dec 2019
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21600589Krakauer 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.
PubMed 16415682Nudo 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.
PubMed 21600588Smith 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.
PubMed 10607127Walker 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.
PubMed 12123620Walker 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.
PubMed 15964485Walker MP. Sleep-dependent memory processing. Harv Rev Psychiatry. 2008;16(5):287-98. doi: 10.1080/10673220802432517.
PubMed 18803104Walker MP, Stickgold R. Sleep, memory, and plasticity. Annu Rev Psychol. 2006;57:139-66. doi: 10.1146/annurev.psych.56.091103.070307.
PubMed 16318592Milner 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.
PubMed 16540232Korman 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.
PubMed 17694051Siengsukon 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.
PubMed 18250068Nishida 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.
PubMed 17406665Backhaus 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.
PubMed 16931152Debas 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.
PubMed 20876115Fogel 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.
PubMed 28422976
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Neural Mechanisms Associated With Sleep-Dependent Enhancement of Motor Learning After Brain Injury
- ClinicalTrials.gov ID
- NCT04810442
- Acronym / sponsor ID
- R-1061-19
- Conditions
- Traumatic Brain Injury
- Keywords
- functional MRI, Motor Learning, Nap, Sleep Benefits, Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 31 Mar 2022 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 23 Mar 2021 (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.
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.
Detailed description
Procedural memory is vitally important to the efficacy of rehabilitation following Traumatic Brain Injury (TBI). Specifically, during rehabilitation, persons with TBI must re-learn many motor skills associated with activities of daily living to improve functional outcomes. Emerging research on neuroplasticity after brain damage is beginning to increase our understanding of motor learning principles and how they interact with the training that takes place in neurorehabilitation.
There is a strong body of evidence showing the importance of sleep in procedural learning among healthy individuals. Within this body of research on sleep and procedural learning, there is substantial evidence demonstrating sleep-dependent neuroplasticity. Participants trained on a motor learning task show improvements over the training period, as expected. However, when re-tested after a period of sleep, performance is significantly better than when retested after an equivalent period of time awake. The actual enhancement of a learned motor skill in the absence of additional practice trials suggests that one can decrease the time necessary for learning a motor skill by incorporating a daytime nap after a period of training. The implications of these findings can be ground-breaking when applied to brain injury rehabilitation where motor learning may be a major focus of physical and occupational therapies. There is evidence of a positive impact of sleep on procedural memory and rehabilitation progress among older individuals after stroke, and the investigators have pilot data showing a substantial positive effect of a post-training nap on motor learning in an acquired brain injury sample. However, the neural mechanisms involved in this process after traumatic brain injury are less understood.
Among healthy individuals, there are numerous studies examining neural biomarkers that can quantify the effect of sleep on motor learning. Studies have reported that changes in sleep physiology and neural activation after training correlate with the degree of improvement at post-intervention testing. Studies showed that, after a nap of 60-90 minutes, speed of performance was enhanced, and the degree of enhancement was associated with the duration of stage 2 non-rapid eye movement (NREM) sleep. This relationship with stage 2 NREM sleep has also been shown after a 20-minute nap. In addition, changes in neural activation in the striatum have been found to be more pronounced when individuals slept after training than when they remained awake. In another study in which a night of sleep occurred between training and retest, changes in striatal activity were correlated with performance gains on the motor learning task. This study also showed evidence of EEG changes during sleep after the training period in the amount of sleep-spindle activity, a waveform associated with stage 2 NREM sleep.
While our preliminary findings show evidence of off-line motor learning after a nap among individuals with acquired brain injury, research into the mechanisms of action driving this response among individuals with TBI is lacking. A better understanding of neurophysiology and its influence on the magnitude of the effect is a crucial step in determining which individuals would be likely to benefit from this behavioral intervention.
Specific Aim 1-Behavioral Intervention: In a sample of individuals with TBI living in the community, demonstrate greater improvement on a motor sequence learning task after a daytime nap compared with an equivalent time spent awake and resting. This aim will also explore the individual differences in terms of demographics and injury characteristics contributing to the magnitude of the effect.
Hypothesis 1. Individuals exposed to a nap after a period of training on the motor sequence learning task will demonstrate greater improvement in speed and accuracy from the end of training to the post-nap retesting.
Research Question 1. How does the magnitude of the effect correlate with demographic factors and injury characteristics? Specific Aim 2-Functional Neuroimaging: To examine the neural correlates of off-line motor learning among individuals with TBI who were given a nap after training on the motor sequence learning task using functional MRI compared with a control group who received an equivalent period of time awake.
Hypothesis 2. Individuals in the nap group will show more pronounced changes in activation within the striatum and motor cortex compared with those who remained awake and resting.
Specific Aim 3-Sleep Physiology: To examine aspects of stage 2 sleep associated with performance gains (duration of stage 2 and degree of spindle activity) occurring during the nap period after training.
Hypothesis 3a. Among participants in the nap group, there will be a significant positive correlation between the degree of improvement and the duration of stage 2 sleep.
Hypothesis 3b. Among participants in the nap group, there will be a significant positive correlation between the degree of improvement and density of sleep spindles.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nap Group | Experimental | Other: NapThis group will be involved with taking a nap in between the two scanning procedures. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
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 |
|---|---|---|
| Nap45-minute nap between scanning procedures | Other | Nap Group |
Primary outcome
Tapping Task Performance Gain
Time frame: through study completion, an average of 2 years
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.
Bold Signal Change
Time frame: through study completion, an average of 2 years
Beta weights associated with the Nap and Rest Groups.
Number of Sleep Spindles
Time frame: through study completion, an average of 2 years
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Background: PubMed 21600589Kleim 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.
- Background: PubMed 16415682Krakauer 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.
- Background: PubMed 21600588Nudo 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.
- Background: PubMed 10607127Smith 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.
- Background: PubMed 12123620Walker 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.
- Background: PubMed 15964485Walker 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.
- Background: PubMed 18803104Walker MP. Sleep-dependent memory processing. Harv Rev Psychiatry. 2008;16(5):287-98. doi: 10.1080/10673220802432517.
- Background: PubMed 16318592Walker MP, Stickgold R. Sleep, memory, and plasticity. Annu Rev Psychol. 2006;57:139-66. doi: 10.1146/annurev.psych.56.091103.070307.
- Background: PubMed 16540232Milner 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.
- Background: PubMed 17694051Korman 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.
- Background: PubMed 18250068Siengsukon 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.
- Background: PubMed 17406665Nishida 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.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
Cortical Spreading Depolarization After Severe Traumatic Brain Injury
Traumatic Brain Injury
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
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.
Anthony Lequerica, Ph.D. principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap in people with Traumatic Brain Injury, run by Kessler Foundation 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 6 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 23 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anthony Lequerica, Ph.D. (973-324-8454, alequerica@kesslerfoundation.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tapping Task Performance Gain (time frame: through study completion, an average of 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04810442, which also lists 15 linked publications.
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 23 Mar 2021; AzTrials last refreshed its copy on 31 Oct 2026.