Traumatic Brain InjurySPTTBINCT01838811
Applying Speed of Processing Training to Individuals With Traumatic Brain Injury
A study testing Speed of Process Training in people with Traumatic Brain Injury, run by Kessler Foundation at 1 site in United States.
Trial summary
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. 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?
- Speed of Process Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2013
- 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
- fluent in English
- processing speed impairment (based on evaluation).
Who cannot join
- currently taking steroids and /or benzodiazepines
- prior stroke or neurological disease
- history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
- significant alcohol or drug abuse history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Applying Speed of Processing Training (SPT) to Individuals With TBI
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with TBI with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the TBI population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in TBI could have a profound impact on the population and society as a whole.
- Conditions
- Traumatic Brain Injury
- Being tested
- Speed of Process Training
- Keywords
- Processing Speed, Intervention, Traumatic Brain Injury, Cognition
- 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.
Speed of Process TrainingBehavioural
SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself. These training tasks are tailored to each individual's ability by the trainer.
What is being measured
The primary outcome is the main question the study is designed to answer.
Processing Speed Performance
Neuropsychological tests which measure processing speed will be used to determine whether there has been a change in performance.
Measured: week 6 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2013 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
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
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy Chiaravalloti, Kessler Foundation
- Investigators
- Nancy Chiaravalloti, Ph.D., Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01838811
- Sponsor's protocol ID
- KF 30.01
- Acronym
- SPTTBI
- Status last verified
- Apr 2015
- First submitted
- 11 May 2012
- Last updated
- 3 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Speed of Processing Training (SPT) to Individuals With TBI
- ClinicalTrials.gov ID
- NCT01838811
- Acronym / sponsor ID
- SPTTBI / KF 30.01
- Conditions
- Traumatic Brain Injury
- Keywords
- Processing Speed, Intervention, Traumatic Brain Injury, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 24 Apr 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.
This pilot study will document the efficacy of a behavioral intervention for Processing Speed (PS) in Traumatic Brain Injury (TBI), Speed of Processing Training (SPT), which has been successful used in the aging population in several studies. This study will (1) apply a treatment protocol for PS impairments, well-validated in aging, to persons with TBI with impaired PS, and document its efficacy on standard neuropsychological (NP) tests (2) assess the effectiveness of the intervention utilizing global measures of daily life, including an objective measure (TIADL) (3) examine the long term impact of SPT. This study is unique in that it will be the first to evaluate the efficacy of a highly-manualized structured behavioral treatment for processing speed deficits in persons with TBI utilizing the optimal methodology for carrying out such studies, a randomized clinical trial. Given the prevalence of PS deficits in the TBI population and the significant impact such deficits have on everyday functioning, public safety, and overall quality of life, the identification of an effective intervention for PS deficits in TBI could have a profound impact on the population and society as a whole.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- fluent in English
- processing speed impairment (based on evaluation).
Key exclusion criteria (4 listed)
- currently taking steroids and /or benzodiazepines
- prior stroke or neurological disease
- history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
- significant 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 |
|---|---|---|
| Speed of Process TrainingSPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself. These training tasks are tailored to each individual's ability by the trainer. | Behavioural | – |
Primary outcome
Processing Speed Performance
Time frame: week 6 and week 12
Neuropsychological tests which measure processing speed will be used to determine whether there has been a change in performance.
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 3 Apr 2015.
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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.
Nancy Chiaravalloti, 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 Speed of Process Training 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 2 inclusion and 4 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 3 Apr 2015. 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?
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?
Processing Speed Performance (time frame: week 6 and week 12). 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 3 Apr 2015.