Training in Goal-directed Attention Regulation for Individuals With Brain Injury
18 oktober 2017 uppdaterad av: VA Office of Research and Development
Plasticity in Brain Network to Enhance Cognitive Rehabilitation
Brain injuries affect the lives of numerous Veterans.
This study examines how the brain is affected by injury and how rehabilitation training for attention dysfunction may change brain functioning.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
Traumatic brain injuries (TBI) are a leading cause of long-term disability among combat Veterans.
The most common and persistent sequelae after TBI are cognitive-behavioral deficits in 'executive control' and 'attention' functions.
Such abnormalities may directly contribute to poor long-term outcomes as well as impede rehabilitation of dysfunction in other cognitive and motor domains.
Effective treatments would potentially make a major impact in improving functional outcomes, but consistently effective treatments are not available.
The overall goal of this research is to improve the investigators' understanding of plasticity in brain function after TBI and to develop improved cognitive neurorehabilitation treatments.
The intervention involves individual and group-based training in cognitive skills.
Studietyp
Interventionell
Inskrivning (Faktisk)
49
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
California
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Sacramento, California, Förenta staterna, 95655
- VA Northern California Health Care System, Mather, CA
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år till 75 år (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- history of traumatic brain injury
- greater than 1 week from injury
- residual dysfunction related to attention and executive control
Exclusion Criteria:
- aphasia
- active illicit drug use
- severe depression
- contraindications to MRI scanning
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Goal-oriented Attention Regulation Training
training in goal-directed attention regulation
|
training in goal-directed attention regulation
|
|
Aktiv komparator: Education
brain health education
|
brain health education workshops
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Experimentell: Technology-assisted Goal-directed Self-Regulation Training
computer-assisted training in goal-directed attention regulation
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computer-assisted training in goal-directed attention regulation, with trainer guidance and cognitive games to practice skills
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Self-report
Tidsram: 5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
|
Responses to goal processing questionnaire relating to areas of personal goal-based functioning.
This scale measured participants self-perceived changes to their cognitive and emotional functioning.
Participants indicated the degree to which they perceived changes to 11 questions after receiving trainings in Arm 1 and Arm 3 on a 10-point scale (1=domain became worse, 5 = no change, 10 = domain improved).
Participants did not complete this measure after Arm 2.
|
5 Weeks (After completion of active trainings in Arm 1 and Arm 3)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change From Baseline to Post-training for Task Errors on a Functional Performance Measure
Tidsram: 5 weeks (After completion of Arm 1 and Arm 2)
|
Participants completed a functional assessment task, the modified Multiple Errands Task (MET).
The MET is an unstructured functional task that permits assessment of participants' abilities to follow outlined rules and complete multiple 'real-world' tasks in a limited time period.
Participants were provided written instructions and a map of the hospital where the assessment took place, and were instructed to complete 12 subtasks in 40 minutes while following 9 specified rules.
Participants completed this at task at baseline and following Training (Arms 1 & 2, but not 3).
Outcome measure was computed as post-training - baseline (negative value reflects less errors made post-training).
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5 weeks (After completion of Arm 1 and Arm 2)
|
|
Change to Attention and Executive Functioning Composite Scores
Tidsram: 5 weeks (After completion of Arm 1 and Arm 2)
|
Participants completed the following neuropsychological measures of attention and executive functions before and after Arms 1 and 2, but not Arm 3. Letter Number Sequencing from WIAT-III; Auditory Consonant Trigram: 9,18, 36 seconds; Digit Vigilance Test (Time and Errors); DKEFS subtests: Design Fluency, Verbal Fluency Switching, Inhibition (Time and Errors); and Inhibition/Switching (Time and Errors); and Trails B. Performance on these measures were scored based upon age, and when available, educational and repeated administration norms. Resultant scores were transformed into z-scores and aggregated to form a composite measure. Higher z-scores reflect better functioning. The unit of analysis for this outcome was the change score from baseline to post-training. Positive change scores reflect improved performance over time[post-training - baseline], whereas negative change scores reflect worsening performance over time. |
5 weeks (After completion of Arm 1 and Arm 2)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Samarbetspartners
Utredare
- Huvudutredare: Mark D'Esposito, MD, VA Northern California Health Care System, Mather, CA
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Chen AJ, Novakovic-Agopian T, Nycum TJ, Song S, Turner GR, Hills NK, Rome S, Abrams GM, D'Esposito M. Training of goal-directed attention regulation enhances control over neural processing for individuals with brain injury. Brain. 2011 May;134(Pt 5):1541-54. doi: 10.1093/brain/awr067. Epub 2011 Apr 22.
- Novakovic-Agopian T, Chen AJ, Rome S, Abrams G, Castelli H, Rossi A, McKim R, Hills N, D'Esposito M. Rehabilitation of executive functioning with training in attention regulation applied to individually defined goals: a pilot study bridging theory, assessment, and treatment. J Head Trauma Rehabil. 2011 Sep-Oct;26(5):325-38. doi: 10.1097/HTR.0b013e3181f1ead2.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 september 2009
Primärt slutförande (Faktisk)
1 december 2015
Avslutad studie (Faktisk)
1 april 2017
Studieregistreringsdatum
Först inskickad
16 december 2009
Först inskickad som uppfyllde QC-kriterierna
16 december 2009
Första postat (Uppskatta)
18 december 2009
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 oktober 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 oktober 2017
Senast verifierad
1 oktober 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- B4605-I
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .