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NCT03169647
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
NA trial testing Listening-based intervention in Brain Injuries, Traumatic in 18 participants. Completed in 30 June 2019.
30 June 2019
Quick facts
| Lead sponsor | Kessler Foundation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | triple |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 17 August 2017 |
| Primary completion | 30 June 2019 |
| Estimated completion | 30 June 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Listening-based intervention
Conditions studied
- Brain Injuries, Traumatic — all drugs for Brain Injuries, Traumatic →
Sponsor
Kessler Foundation
Who can join
Adults 18 to 59, any sex, with Brain Injuries, Traumatic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly reduce quality of life for individuals with TBI as functioning in this domain has been closely linked with successful independent living and community re-integration. Problematically, there are currently no empirically validated treatment options that address metacognitive deficits after TBI. Recent research in healthy samples demonstrates that specific listening interventions may alter neural activation in brain works associated with metacognition and can improve metacognitive functioning; however, it remains unknown if these effects generalize to individuals with TBI. Thus, the objective of the proposed study is to use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of applying a specific listening intervention to improve metacognition after TBI and to employ functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the intervention operates.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03169647
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Related trials
Other recruiting trials for Brain Injuries, Traumatic
Currently open trials in the same condition.
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- NCT05117619 — The HOME Program for Individuals With Traumatic Brain Injury and Family Members · NA · recruiting
- NCT05092295 — Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury · active not recruiting
Other Kessler Foundation trials
Trials by the same sponsor.
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- NCT07159100 — tDCS for Cancer-Related Fatigue and Weakness · EARLY_PHASE1 · not yet recruiting
- NCT06886152 — Spinal Stimulation and Gait Training to Improve Mobility in TBI · NA · not yet recruiting
- NCT07073313 — Using Muscle Functional MRI to Study Spatial Muscle Activation Patterns in People With SCI · not yet recruiting
- NCT06923293 — Improving Walking After a Lower Limb Injury Using a Custom Motorized Orthosis · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03169647 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Kessler Foundation
- Last refreshed: 23 October 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03169647.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing