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NCT03814356 · ClinicalTrials.gov registry record · Phase 1
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
A Phase 1 study of Coma and Anoxic Brain Injury, sponsored by Massachusetts General Hospital.
- Active
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03814356: Active Phase 1 study of Coma and Anoxic Brain Injury, sponsored by Massachusetts General Hospital.
NCT03814356 is a Phase 1 study of Coma and Anoxic Brain Injury that is active but no longer recruiting, run by Massachusetts General Hospital. The registered enrollment target is 10 participants, below the 85-participant average among 3 other Coma trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03814356, a Phase 1 study of Coma and Anoxic Brain Injury, is active but no longer recruiting, sponsored by Massachusetts General Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Adverse Events An AE is defined as any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). In the STIMPACT Trial an AE may include, but is not limited to: * Sustained hypertension = SBP \> 200 mmHg or DBP \> 120 mmHg for \> 30 min, refractory to medical therapy, or * Sustained tachycardia = HR \> 120 bpm for \> 30 min, refractory to medical therapy, or * Sustained intracranial hypertension = ICP \
Conditions Studied
Interventions
- DRUG Methylphenidate
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2020-08-24 |
| Est. Completion | 2026-06-30 |
| Phase | Phase 1 |
What the registry record for NCT03814356 still lists
NCT03814356 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 85-participant average among 3 other Coma trials with a reported enrollment target (88% lower).
The record links to 4 conditions, with Coma appearing as the primary indexed condition, and to 1 intervention - of which Methylphenidate is the first listed.
NCT03814356 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT03814356 about?
NCT03814356 is a clinical study titled "Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness". 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.
What is the current status of trial NCT03814356?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2020-08-24. Estimated completion is 2026-06-30.
What conditions does trial NCT03814356 study?
This clinical trial studies the following conditions: Coma, Anoxic Brain Injury, Consciousness, Level Altered, Brain Injury Traumatic Severe (Diagnosis).
What interventions are being tested in trial NCT03814356?
The interventions under investigation include: Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT03814356?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03814356 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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