Ketamine, SGB and Combination Treatment for TBI

Launched by NORTHWESTERN UNIVERSITY · Sep 19, 2024

Keywords

ClinConnect Summary

This clinical trial, titled "Ketamine, SGB and Combination Treatment for TBI," is investigating how effective two treatments—ketamine and a procedure called stellate ganglion block (SGB)—are in helping people who have experienced post-traumatic stress disorder (PTSD) and headaches related to traumatic brain injury (TBI). The goal is to see if either treatment alone, or a combination of both, can reduce symptoms and improve the quality of life for individuals dealing with these challenges. The study will also look at how different factors might influence whether a person responds well to treatment.

To participate in the trial, individuals need to be at least 18 years old and have had symptoms of TBI or PTSD for more than three months. They should also be on stable doses of their current medications for at least two weeks. However, people who have received ketamine or SGB treatments in the last six months, have serious medical conditions that could affect their participation, or are pregnant will not be eligible. Participants can expect to be part of a study that is carefully controlled to ensure safety and effectiveness, with the hope of finding better treatment options for TBI and PTSD.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Adults 18 years or older
• • 2. Stable doses of medications for \> 2 weeks for TBI and/or PTSD
• • 3. For TBI-associated headache with or without PTSD: HIT-6 score of \>/=53. For PTSD with or without TBI-associated headache: PCL-5 score \>/=33 OR. For those with TBI and PTSD, and a HIT-6 score \< 53 and PCL-5 score of \<33, individuals with a HIT-6 score of 50-52 and a PCL-5 score of 31 or 32 will be included.
• • 4. Duration of chronic TBI or PTSD \> 3 months
• Exclusion Criteria:
• • 1. Ketamine infusion or SGB within the past 6 months
• • 2. Serious medical or psychiatric conditions other than TBI or PTSD that could affect cognition (e.g., dementia, Parkinson's Disease)
• • 3. Elevated intracranial pressure
• • 4. For TBI, prior history of headache that can explain the headache intensity (i.e., headache not attributable to TBI)
• • 5. Active psychosis or poorly controlled non-injury or PTSD-related psychiatric condition (e.g., bipolar disorder)
• • 6. Poorly controlled medical conditions that could be exacerbated by treatment (e.g., unstable angina)
• • 7. Pregnancy (women of childbearing age who can become pregnant will have to take a pregnancy test)
• • 8. Non-fluency in English (poor generalizability to military and veteran populations, instruments not validated for use or translated in many languages)