Status:
ACTIVE_NOT_RECRUITING
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Brain Injury Traumatic Severe (Diagnosis)
Coma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 i...
Detailed Description
To be classified as having a DoC, a patient must be in a coma, vegetative state (VS), or minimally conscious state (MCS), as determined by behavioral assessment using the Coma Recovery Scale-Revised (...
Eligibility Criteria
Inclusion
- Age ≥ 18 years
- Severe, acute traumatic brain injury
- Diagnosis of Coma, Vegetative State, or Minimally Conscious State
Exclusion
- 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
- Cardiovascular
- Poorly controlled hypertension (SBP \> 200 mmHg of DBP \> 120mmHg for 30 minutes, despite anti-hypertensive therapy, within the past 24 hours)
- Coronary artery disease
- ST elevation myocardial infarction
- Acute coronary syndrome
- Hemodynamically significant dysrhythmia
- Congestive heart failure
- Cardiomyopathy (including Takotsubo cardiomyopathy)
- Other severe structural cardiac abnormalities
- Renal
- a. Renal failure requiring renal replacement therapy (e.g. CVVH or HD)
- Endocrine
- a. History of or clinical suspicion for thyrotoxicosis
- Reproductive
- a. Pregnancy
- Ophthalmologic
- a. History of glaucoma
- Pharmacologic
- a. Monoamine oxidase inhibitor therapy within past 14 days
- Other
- Any condition or finding that in the judgment of the PI or treating clinical team significantly increases the risk or significantly decreases the likelihood of a response to IV MPH
Key Trial Info
Start Date :
August 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03814356
Start Date
August 24 2020
End Date
June 30 2026
Last Update
October 29 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114