NCT02236676

Brief Summary

The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 28, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 10, 2014

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

5 years

First QC Date

September 8, 2014

Last Update Submit

August 30, 2021

Conditions

Motor Learning in TBI

Keywords

motor learning TBI

Outcome Measures

Primary Outcomes (1)

  • Improvement on Motor Functioning Test

    Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions

    Three Nights and Three Days

Study Arms (2)

Nap after rehearsal trials

ACTIVE COMPARATOR

A 30-minute daytime nap after training

Behavioral: Nap after rehearsal trials

Resting while awake

PLACEBO COMPARATOR

Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed.

Behavioral: Nap after rehearsal trials

Interventions

Nap after rehearsal trialsBEHAVIORAL

Behavioral

Nap after rehearsal trialsResting while awake

Eligibility Criteria

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

You may qualify if:

  • Must have a Traumatic Brain Injury.
  • Must have been a Kessler Institute for Rehabilitation inpatient for at least three days.

You may not qualify if:

  • Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh.
  • Movement disorder or spasticity affecting both upper extremities
  • Patients who are ventilator-dependent.
  • Patients who are on contact precautions for C.diff or other highly contagious diseases.
  • Patients with neurological disorders other than TBI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Scientist

Study Record Dates

First Submitted

September 8, 2014

First Posted

September 10, 2014

Study Start

May 28, 2014

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

September 5, 2021

Record last verified: 2021-08

Locations

US(1)