Traumatic Brain InjuryNCT01993407
Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
A study testing Task Switching Training in people with Traumatic Brain Injury and Brain Injuries, Traumatic, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury. Read more about this study
- Who is it for?
- Ages 19 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Brain Injuries, Traumatic
- What is being tested?
- Task Switching Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Jun 2015
- 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 19 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage.
- If you are between the ages of 19 and 65.
Who cannot join
- For participants with Traumatic Brain Injury:
- If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor).
- If your Brain injury is less than 6 months ago.
- For healthy participants:
- -If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor).
- For All participants:
Show all 10Show fewer
- If you have significant psychiatric history (such as schizophrenia or bipolar disorder.)
- If you have a alcohol or drug abuse history.
- If you are currently taking certain types of medications, which the study doctor will review.
- If you do not have a working knowledge of the English Language.
Trial locations and contacts
1 site in 1 country.
United States1 site
Kessler Foundation Research Center
West Orange, New Jersey, 07052
About this study
The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.
- Conditions
- Traumatic Brain Injury, Brain Injuries, Traumatic
- Being tested
- Task Switching Training, Control Task
- 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.
Task Switching TrainingBehavioural
Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
Control TaskBehavioural
Participants will complete four, one-hour training sessions in which they will perform a single task each session
| Study group | Role | What they receive |
|---|---|---|
| Task Switching Training | Experimental | Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm. Receives: Behavioral: Task Switching Training |
| Pure Task Training | Placebo comparator | Participants will complete four, one-hour training sessions in which they will perform a single task each session, alternating tasks between but not within sessions. Receives: Behavioral: Control Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Commission on Brain Injury Research
- Responsible party
- Sponsor
- Investigators
- Starla Weaver, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01993407
- Sponsor's protocol ID
- R-743-12
- Status last verified
- Aug 2018
- First submitted
- 13 Nov 2013
- Last updated
- 10 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training Executive Functions to Facilitate Recovery Following Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01993407
- Acronym / sponsor ID
- R-743-12
- Conditions
- Traumatic Brain Injury, Brain Injuries, Traumatic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Commission on Brain Injury Research
- Study start
- Jun 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Nov 2013 (estimated)
- 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.
The purpose of this research study is to investigate different types of task training to determine if training improves thinking processes following traumatic brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Task Switching Training | Experimental | Behavioral: Task Switching TrainingParticipants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm. |
| Pure Task Training | Placebo comparator | Behavioral: Control TaskParticipants will complete four, one-hour training sessions in which they will perform a single task each session, alternating tasks between but not within sessions. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- If you have had a Traumatic Brain Injury (TBI)or no history of neurological disease/damage.
- If you are between the ages of 19 and 65.
Key exclusion criteria (10 listed)
- If you have a history of prior neurological disorders (e.g., stroke, seizures, or brain tumor).
- If your Brain injury is less than 6 months ago.
- -If you have a history of prior neurological disorders (e.g., head injury, stroke, seizures, or brain tumor).
- If you have significant psychiatric history (such as schizophrenia or bipolar disorder.)
- If you have a alcohol or drug abuse history.
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 |
|---|---|---|
| Task Switching TrainingParticipants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm. | Behavioural | Task Switching Training |
| Control TaskParticipants will complete four, one-hour training sessions in which they will perform a single task each session | Behavioural | Pure Task Training |
Primary outcome
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2018.
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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.
Starla Weaver, PhD 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 Task Switching Training in people with Traumatic Brain Injury and Brain Injuries, Traumatic, 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 2 inclusion and 10 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: finished, as of the sponsor's last update on 10 Aug 2018. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in switch costs, measured via response time in milliseconds on task switch trials minus response time on task repetition trials, from baseline (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Aug 2018.