Ignite Creation Date:
2024-05-19 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413173
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-04-30
Brief Title:
Remotely Supervised tDCS for Complex Attention in mTBI Cognetric
Sponsor:
United States Naval Medical Center San Diego
Organization:
United States Naval Medical Center San Diego
Study Overview
Official Title:
Remotely Supervised tDCS Combined With Cognitive Training to Improve Complex Attention in Active Duty Service Members and Veterans With Mild TBI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The proposed study will evaluate a new approach to cognitive rehabilitation of mTBI using a brain stimulation technique called Remotely Supervised Transcranial Direct Current Stimulation combined with Cognitive Training RS-tDCS which has shown promise for improving complex attention in both healthy and clinical populations RS-tDCS is a home-based low-risk non-invasive technique that is designed to boost cognitive training by enhancing learning and the brains ability to reorganize connections This study will evaluate RS-tDCS for improving complex attention in Active Duty Service Members ADSM and Veterans with a history of mTBI Different tests of complex attention and symptom questionnaires will be used to determine the effects of real versus sham placebo RS-tDCS Second the investigators will investigate electrical and connectivity changes in the brain associated with RS-tDCS using electroencephalogram EEG and magnetic resonance imaging MRI Third the investigators will investigate the lasting effects of any observed changes by evaluating participants at 1 and 6 weeks post-treatment Lastly the investigators will explore the impact of individual differences eg PTSD depression sleep quality time since injury baseline impairment age sex ADSM versus Veteran on treatment outcome
Detailed Description:
Objectives
Attention concentration and working memory ie complex attention deficits are the most reported neurocognitive sequelae of mild traumatic brain injury mTBI and have been associated with patterns of decreased neural activation Existing cognitive rehabilitation interventions require significant time and effort and are limited by small-to-moderate effect sizes and uncertain durabilitygeneralization of effects Novel neuroplasticity-based interventions that improve complex attention and can be administered remotely are needed to increase access to care decrease recovery time and improve outcomes and quality of life following mTBI This multi-site study will investigate remotely-supervised tDCS RS-tDCS combined with cognitive training in the chronic phase of recovery 3 months from mTBI to 1 increase accessibility to care 2 improve cognitive functioning post-concussion symptom outcomes and quality of life and 3 investigate the durability of the intervention in Active Duty Service Members ADSM at the Naval Medical Center San Diego NMCSD and Veterans at the Minneapolis VA Health care System MVAHCS
Research Plan and Methods
This is a double-blind randomized sham-controlled study 80 Veterans from the MVAHCS and 80 ADSM from NMCSD total N160 will be recruited Participants will have a history of mTBI and self-reported attention andor concentration difficulties Baseline assessment will include self-reported symptoms and objective neurocognitive performance Resting state functional connectivity changes will be measured with functional magnetic resonance imaging fMRI and oscillatory brain activity will be measured with EEG both collected at baseline and at post-intervention assessments Participants will be randomized to either active RS-tDCS or sham RS-tDCS using stratified randomization by baseline cognitive scores The intervention sessions will occur in the participants home 10 sessions within 2 weeks Two post-intervention assessments mirroring the baseline assessment will occur approximately 1 week and 6 weeks after the intervention Additionally the investigators will collect longitudinal real-time data daily on TBI symptoms cognitive and mood factors during the 6 weeks post-intervention using Ecological Momentary Assessment EMA
Clinical Relevance
RS-tDCS addresses two major obstacles of current TBI treatments Accessibility and adherence RS-tDCS offers several benefits as it can be monitored remotely and can be self-administered in the home after the first session If RS-tDCS proves effective this non-invasive intervention could dramatically improve access to a validated treatment that can be rapidly implemented within various DOD and VA settings to reduce TBI-related symptoms improve cognition enhance recovery bolster occupational performance and improve quality of life
Attention concentration and working memory ie complex attention deficits are the most reported neurocognitive sequelae of mild traumatic brain injury mTBI and have been associated with patterns of decreased neural activation Existing cognitive rehabilitation interventions require significant time and effort and are limited by small-to-moderate effect sizes and uncertain durabilitygeneralization of effects Novel neuroplasticity-based interventions that improve complex attention and can be administered remotely are needed to increase access to care decrease recovery time and improve outcomes and quality of life following mTBI This multi-site study will investigate remotely-supervised tDCS RS-tDCS combined with cognitive training in the chronic phase of recovery 3 months from mTBI to 1 increase accessibility to care 2 improve cognitive functioning post-concussion symptom outcomes and quality of life and 3 investigate the durability of the intervention in Active Duty Service Members ADSM at the Naval Medical Center San Diego NMCSD and Veterans at the Minneapolis VA Health care System MVAHCS
Research Plan and Methods
This is a double-blind randomized sham-controlled study 80 Veterans from the MVAHCS and 80 ADSM from NMCSD total N160 will be recruited Participants will have a history of mTBI and self-reported attention andor concentration difficulties Baseline assessment will include self-reported symptoms and objective neurocognitive performance Resting state functional connectivity changes will be measured with functional magnetic resonance imaging fMRI and oscillatory brain activity will be measured with EEG both collected at baseline and at post-intervention assessments Participants will be randomized to either active RS-tDCS or sham RS-tDCS using stratified randomization by baseline cognitive scores The intervention sessions will occur in the participants home 10 sessions within 2 weeks Two post-intervention assessments mirroring the baseline assessment will occur approximately 1 week and 6 weeks after the intervention Additionally the investigators will collect longitudinal real-time data daily on TBI symptoms cognitive and mood factors during the 6 weeks post-intervention using Ecological Momentary Assessment EMA
Clinical Relevance
RS-tDCS addresses two major obstacles of current TBI treatments Accessibility and adherence RS-tDCS offers several benefits as it can be monitored remotely and can be self-administered in the home after the first session If RS-tDCS proves effective this non-invasive intervention could dramatically improve access to a validated treatment that can be rapidly implemented within various DOD and VA settings to reduce TBI-related symptoms improve cognition enhance recovery bolster occupational performance and improve quality of life
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None