Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06608277
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-18
Brief Title:
Ketamine SGB and Combination Treatment for TBI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Multi-Center Randomized Double-Blind Placebo-Controlled Trial Comparing Ketamine Stellate Ganglion Blocks and Combination Treatment to Sham Therapies for Traumatic Brain Injury-Associated Headaches and Post-Traumatic Stress Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Post-Traumatic Stress Disorder PTSD and traumatic brain injury TBI with associated headache are amongst the most common injuries sustained by our deployed forces in Iraq and Afghanistan as well as in more recent conflicts in Eastern Europe and the Middle East This study aims to determine whether a procedural intervention stellate ganglion block SGB or medication ketamine alone or in combination can alleviate PTSD and TBI-associated headache Determining efficacious treatments in a randomized double-blind placebo-controlled multicenter study trial may improve quality of life in those with TBI and PTSD and identifying factors associated with treatment outcome personalized medicine may enhance selection thereby improving the risk benefit and cost-effectiveness ratios
Primary Objectives
1 To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache
2 To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD
3 To determine the comparative effectiveness of SGB and ketamine infusion and the effect of combination treatment on TBI-related headache and PTSD
4 Exploratory Aim 1 To determine the effects of SGB ketamine infusion and the combination on structural and functional MRI biomarker levels and pain thresholds and tolerance
5 Exploratory Aim 2 To identify factors associated with treatment responders overall and for individual treatment groups
Secondary Objectives
1 Exploratory Aim 1 To determine the effects of SGB ketamine infusion and the combination on structural and functional MRI biomarker levels and pain thresholds and tolerance Biomedical levels and MRI not included at Northwestern University Site
2 Exploratory Aim 2 To identify factors associated with treatment responders overall and for individual treatment groups
Primary Objectives
1 To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for TBI-related headache
2 To determine the efficacy of SGB and ketamine infusion as stand-alone treatments for PTSD
3 To determine the comparative effectiveness of SGB and ketamine infusion and the effect of combination treatment on TBI-related headache and PTSD
4 Exploratory Aim 1 To determine the effects of SGB ketamine infusion and the combination on structural and functional MRI biomarker levels and pain thresholds and tolerance
5 Exploratory Aim 2 To identify factors associated with treatment responders overall and for individual treatment groups
Secondary Objectives
1 Exploratory Aim 1 To determine the effects of SGB ketamine infusion and the combination on structural and functional MRI biomarker levels and pain thresholds and tolerance Biomedical levels and MRI not included at Northwestern University Site
2 Exploratory Aim 2 To identify factors associated with treatment responders overall and for individual treatment groups
Detailed Description:
This is a multicenter randomized double-blind subject evaluator placebo-controlled parallel-group clinical trial where 175 eligible subjects will be randomized into 1 of 4 groups described below using a 2221 ratio The purpose of the trial is to test the efficacy and comparative effectiveness of SGB and ketamine infusion on PTSD and post-traumatic headache There are no reliably effective treatments for either PTSD or TBI-associated headaches with preliminary andor conflicting results suggesting efficacy for both SGB and ketamine for both conditions
The first three groups will receive at least one intervention with a smaller number receiving sham SGB placebo ketamine which is necessary to determine efficacy and serve as a comparator Several patient-reported outcomes including quality of life measures will be collected at baseline and the primary endpoint at 4 weeks Those with a positive categorical response described under data collection will be followed further at 8 and 12 weeks Those with negative outcomes will exit the study and be followed as an observational cohort where they will be eligible for non-study measures as determined by the treating providers This may include other novel treatments such as using higher doses of ketamine sympathetic blocks with botulinum toxin and liposomal bupivacaine and the use of neuromodulation
The first three groups will receive at least one intervention with a smaller number receiving sham SGB placebo ketamine which is necessary to determine efficacy and serve as a comparator Several patient-reported outcomes including quality of life measures will be collected at baseline and the primary endpoint at 4 weeks Those with a positive categorical response described under data collection will be followed further at 8 and 12 weeks Those with negative outcomes will exit the study and be followed as an observational cohort where they will be eligible for non-study measures as determined by the treating providers This may include other novel treatments such as using higher doses of ketamine sympathetic blocks with botulinum toxin and liposomal bupivacaine and the use of neuromodulation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None