Active — Not RecruitingPhase 1

Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness

United States10 participantsStarted 2020-08-24

Plain-language summary

Phase 1 of the STIMPACT trial is an open label,dose-escalation,safety study of intravenous (IV) methylphenidate (MPH) therapy in patients with disorders of consciousness (DoC) caused by severe brain injuries.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age ≥ 18 years
✓. Severe, acute traumatic brain injury
✓. Diagnosis of Coma, Vegetative State, or Minimally Conscious State

Exclusion criteria

✕. Penetrating brain injury caused by a metallic missile/object (e.g. bullet)
✕. Body metal contraindicating MRI
✕. Prisoner or ward of the state
✕. Neurological
✕. Bilateral dilated unresponsive pupils
✕. Intracranial hypertension (Intracranial Pressure \[ICP\] \> 25 mmHg for \> 5 min within past 24 hours with head-of-bed at standard clinical angle of 30-45 degrees)
✕. Intracranial bolt
✕. Status epilepticus or concern for post-ictal state

What they're measuring

Number of Participants With Adverse Events at Each Dose

Timeframe: 4 Days

Trial details

NCT IDNCT03814356

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-01

Results submitted2025-08-12

View on ClinicalTrials.gov More Brain Injury Traumatic Severe (Diagnosis) trials