Healthy IndividualsPhase 1GRID12007NCT01134978
Neural Mechanisms of the Contextual Interference Effect: A fNIRs and EEG Study
A Phase 1 study testing Practice Order in people with Healthy Individuals and Learning, run by Drexel University at 1 site in United States.
Trial summary
The overall goal of this study is to gain insight into the neural mechanisms of learning multiple tasks. By examination of cognitive and behavioral output during the performance and learning of several computer maze tasks, and through a detailed examination of the neural activity obtained from functional near-infrared… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Individuals, Learning
- What is being tested?
- Practice Order
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2007to Jun 2011
- Phase
- Phase 1
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 55 years of age
- vision correctable to 20/20
- right-handed
- English is first language or learned English before age of 5 years
Who cannot join
- 17 years or younger and 56 years or older
- pregnant
- have latex or tape adhesives allergies
- self-exclude if:
- had a history of seizures, head injury or neurological dysfunction
- history or diagnosis of depression, schizophrenia or social phobia
- previous admission to alcohol/drug treatment program or diagnosis of alcohol/drug abuse
- take medications know to affect neurological function.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cognitive Motor Movement Neuroscience Lab (CoMMoNS) - rm 3612 NCB, Drexel University
Philadelphia, Pennsylvania, 19102
About this study
The overall goal of this study is to gain insight into the neural mechanisms of learning multiple tasks. By examination of cognitive and behavioral output during the performance and learning of several computer maze tasks, and through a detailed examination of the neural activity obtained from functional near-infrared (fNIR) and electroencephalography (EEG), it may be possible to gain insight into the impact of the amount of practice and the organization of practice has on learning fine motor skills. This insight may provide direction as to how to better develop instructional and rehabilitation protocols in addition to clinical interventions to facilitate recovery of function, relearning and transfer of cognitive and fine motor skills based upon neural responses to physical practice.
- Conditions
- Healthy Individuals, Learning
- Being tested
- Practice Order
- Keywords
- repeated measures design, random assignment to groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Practice OrderBehavioural
Also called High contextual interference - random practice schedule, Low contextual interference - blocked practice schedule
Blocked order - predictable
Random order - unpredictable
| Study group | Role | What they receive |
|---|---|---|
| Practice Schedules | Experimental | Subjects are randomly assigned to either a blocked or random practice schedule when learning three 3-D computer mazes. A blocked practice schedule is created when the tasks to be learned are presented in a predictable order, while a random practice schedule has tasks presented in a nonsequential, unpredictable order. Neural activity and behavioral measures will differ for the two practice schedules. For memory and transfer, it is predicted that random practice will be better than blocked practice. Receives: Behavioral: Practice Order |
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic measures of neural activity in the dorsolateral prefrontal cortex
Functional near infrared spectroscopy (fNIR) uses specific wavelets of light, that are introduced at the scalp to measure changes in the relative ratios of deoxygenated hemoglobin and oxygenated hemoglobin in the capillary beds during brain activity.
Measured: outcomes measured 72 - 96 hours post-training
Secondary outcomes (1)
Behavioral measures
maze behavioral responses of time to traverse the maze (sec), distance traveled (pixels)and average maze velocity (pixels/sec) are calculated.
Measured: measured 72-96 hours post training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startNov 2007
- Primary completionDec 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy IndividualsStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Investigators
- Patricia A Shewokis, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01134978
- Sponsor's protocol ID
- 16758
- Acronym
- GRID12007
- Status last verified
- May 2011
- First submitted
- 27 May 2010
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ayaz H, Shewokis PA, Curtin A, Izzetoglu M, Izzetoglu K, Onaral B. Using MazeSuite and functional near infrared spectroscopy to study learning in spatial navigation. J Vis Exp. 2011 Oct 8;(56):3443. doi: 10.3791/3443.
PubMed 22005455Shewokis PA, Ayaz H, Izzetoglu M, Bunce S, Gentili RJ, Sela I, Izzetoglu K, Onaral B. Brain in the Loop: Assessing Learning using fNIR in cognitive and motor tasks. D.D. Schmorrow and C.M. Fidopiastis (Eds.).Lecture Notes in Artificial Intelligence, 6780: 240-249. 2011. Springer-Verlag Berlin Heidelberg 2011.
Shewokis PA, Ayaz H, Izzetoglu K, Izzetoglu M, Bunce SC, Schultheis MT, Pourrezaei K. Dorsolateral prefrontal cortex activity during the learning of computer tasks in a contextual interference paradigm using fNIRs: a case series. Journal of Sport & Exercise Psychology 30: S130. 2008.
Shewokis PA, Ayaz H, Izzetoglu M, Getchell N, Izzetoglu K. the acquisition and learning of computer tasks in a contextual interference paradigm: Using functional near infrared spectroscopy to examine prefrontal cortex activity. Journal of Sport & Exercise Psychology. 32: S127-S128. 2010.
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Mechanisms of the Contextual Interference Effect: A fNIRs and EEG Study
- ClinicalTrials.gov ID
- NCT01134978
- Acronym / sponsor ID
- GRID12007 / 16758
- Conditions
- Healthy Individuals, Learning
- Keywords
- repeated measures design, random assignment to groups
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- Pennsylvania Department of Health
- Study start
- Nov 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 2 Jun 2010 (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 overall goal of this study is to gain insight into the neural mechanisms of learning multiple tasks. By examination of cognitive and behavioral output during the performance and learning of several computer maze tasks, and through a detailed examination of the neural activity obtained from functional near-infrared (fNIR) and electroencephalography (EEG), it may be possible to gain insight into the impact of the amount of practice and the organization of practice has on learning fine motor skills. This insight may provide direction as to how to better develop instructional and rehabilitation protocols in addition to clinical interventions to facilitate recovery of function, relearning and transfer of cognitive and fine motor skills based upon neural responses to physical practice.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Practice Schedules | Experimental | Behavioral: Practice OrderSubjects are randomly assigned to either a blocked or random practice schedule when learning three 3-D computer mazes. A blocked practice schedule is created when the tasks to be learned are presented in a predictable order, while a random practice schedule has tasks presented in a nonsequential, unpredictable order. Neural activity and behavioral measures will differ for the two practice schedules. For memory and transfer, it is predicted that random practice will be better than blocked practice. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 to 55 years of age
- vision correctable to 20/20
- right-handed
- English is first language or learned English before age of 5 years
Key exclusion criteria (8 listed)
- 17 years or younger and 56 years or older
- pregnant
- have latex or tape adhesives allergies
- self-exclude if:
- had a history of seizures, head injury or neurological dysfunction
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 |
|---|---|---|
| Practice OrderAlso: High contextual interference - random practice schedule, Low contextual interference - blocked practice scheduleBlocked order - predictable Random order - unpredictable | Behavioural | Practice Schedules |
Primary outcome
metabolic measures of neural activity in the dorsolateral prefrontal cortex
Time frame: outcomes measured 72 - 96 hours post-training
Functional near infrared spectroscopy (fNIR) uses specific wavelets of light, that are introduced at the scalp to measure changes in the relative ratios of deoxygenated hemoglobin and oxygenated hemoglobin in the capillary beds during brain activity.
1 secondary outcome
Behavioral measures
Time frame: measured 72-96 hours post training
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 7 Nov 2011.
- Results publication: PubMed 22005455Ayaz H, Shewokis PA, Curtin A, Izzetoglu M, Izzetoglu K, Onaral B. Using MazeSuite and functional near infrared spectroscopy to study learning in spatial navigation. J Vis Exp. 2011 Oct 8;(56):3443. doi: 10.3791/3443.
- Results publicationShewokis PA, Ayaz H, Izzetoglu M, Bunce S, Gentili RJ, Sela I, Izzetoglu K, Onaral B. Brain in the Loop: Assessing Learning using fNIR in cognitive and motor tasks. D.D. Schmorrow and C.M. Fidopiastis (Eds.).Lecture Notes in Artificial Intelligence, 6780: 240-249. 2011. Springer-Verlag Berlin Heidelberg 2011.
- Results publicationShewokis PA, Ayaz H, Izzetoglu K, Izzetoglu M, Bunce SC, Schultheis MT, Pourrezaei K. Dorsolateral prefrontal cortex activity during the learning of computer tasks in a contextual interference paradigm using fNIRs: a case series. Journal of Sport & Exercise Psychology 30: S130. 2008.
- Results publicationShewokis PA, Ayaz H, Izzetoglu M, Getchell N, Izzetoglu K. the acquisition and learning of computer tasks in a contextual interference paradigm: Using functional near infrared spectroscopy to examine prefrontal cortex activity. Journal of Sport & Exercise Psychology. 32: S127-S128. 2010.
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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.
Patricia A Shewokis, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Practice Order in people with Healthy Individuals and Learning, run by Drexel University 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 4 inclusion and 8 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 7 Nov 2011. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
metabolic measures of neural activity in the dorsolateral prefrontal cortex (time frame: outcomes measured 72 - 96 hours post-training). 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 NCT01134978, which also lists 4 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 7 Nov 2011.