Clinical TrialTraumatic Brain Injury (TBI)PlaceboKetamineKetaminePlaceboRecruiting

Ketamine, SGB and Combination Treatment for TBI

This randomised, double-blind, placebo-controlled trial (n=175) will investigate the efficacy of stellate ganglion block (SGB) and ketamine infusion, both separately and in combination, in treating PTSD and TBI-associated headache.

Target Enrollment
175 participants
Study Type
Phase II interventional
Design
Randomized, double Blind

Detailed Description

Multicentre, randomized, double-blind, placebo-controlled parallel trial assigning 175 participants in a 2:2:2:1 ratio to SGB, sham SGB, ketamine infusion, placebo infusion, or combination SGB plus ketamine to assess effects on TBI-related headache and PTSD.

Primary outcomes assessed at 4 weeks with additional visits at 1, 2, 8 and 12 weeks and observational follow-up to 6 and 12 months for responders; exploratory imaging and biomarker aims included at select sites.

Interventions: single ultrasound/fluoroscopic SGB with ≈8 mL bupivacaine and IV ketamine infusion (bolus up to 0.3 mg/kg, total 0.5–1 mg/kg over 30–60 minutes); placebo conditions use midazolam and saline as described in protocol.

Study Protocol

Preparation

sessions

Dosing

1 sessions
60 min each

Integration

sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

SGB + placebo ketamine

active comparator

Stellate ganglion block with bupivacaine plus placebo (midazolam/saline) infusion.

Interventions

  • Compound
    via Other• single dose

    Ultrasound/fluoroscopic SGB with ≈8 mL bupivacaine (local anaesthetic).

  • Placebo0 mg
    via IV• single dose

    Placebo ketamine: midazolam 1–7 mg bolus and saline infusion over 30–60 min (described as placebo control).

Sham SGB + ketamine

active comparator

Sham SGB (saline subcutaneous) plus ketamine infusion.

Interventions

  • Compound
    via Other• single dose

    Sham SGB: 1–2 mL saline subcutaneously under imaging guidance.

  • Ketamine1 mg/kg
    via IV• single dose

    Ketamine: bolus up to 0.3 mg/kg then total 0.5–1 mg/kg over 30–60 minutes; midazolam 1–4 mg given prior/with bolus as described.

SGB + ketamine

experimental

Active SGB with bupivacaine plus active ketamine infusion (combination).

Interventions

  • Compound
    via Other• single dose

    SGB with ≈8 mL bupivacaine under ultrasound/fluoroscopy.

  • Ketamine1 mg/kg
    via IV• single dose

    Ketamine infusion: bolus up to 0.3 mg/kg then total 0.5–1 mg/kg over 30–60 min.

Sham SGB + placebo ketamine

inactive

Sham SGB plus midazolam/saline placebo infusion.

Interventions

  • Compound
    via Other• single dose

    Sham SGB: 1–2 mL saline subcutaneously.

  • Placebo0 mg
    via IV• single dose

    Placebo ketamine: midazolam 1–7 mg bolus and saline infusion over 30–60 min.

Participants

Ages
18 – 99
Sexes
Male & Female

Inclusion 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. 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

  • 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)

Study Details

Locations

Anesthesiology Pain Medicine Center — Chicago, Illinois, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Womack Army Medical Center — Fort Bragg, North Carolina, United States

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