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Methylphenidate for Disorders of Consciousness (STIMPACT Trial)
STIMPACT Trial Summary
This trial is testing the safety of giving methylphenidate to people with disorders of consciousness caused by severe brain injuries.
STIMPACT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSTIMPACT Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2020 Phase 4 trial • 267 Patients • NCT02039908STIMPACT Trial Design
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Who is running the clinical trial?
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- I have had a recent heart attack or severe chest pain.I have been diagnosed with congestive heart failure.I have a severe brain injury from a recent accident.You have a medical condition that the doctor thinks could make it more risky or less likely for you to respond to the study medication given through a vein.I have or might have an overactive thyroid.I have been diagnosed with a type of heart muscle disease.My blood pressure is not well controlled, even with medication.I have had a type of heart attack known as ST elevation myocardial infarction.I am 18 years old or older.I am diagnosed with a severe consciousness disorder.You have a device in your head called an "intracranial bolt."I have a serious heart rhythm problem.Both of my pupils are enlarged and do not respond to light.I have had a prolonged seizure or am recovering from one.I have been diagnosed with coronary artery disease.I am on dialysis for kidney failure.I have a history of glaucoma.I haven't taken monoamine oxidase inhibitors in the last 14 days.I have had a brain injury from a metal object like a bullet.You have metal in your body that prevents you from having an MRI.I have not had high pressure inside my skull for more than 5 minutes in the last day.
- Group 1: IV MPH
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies available within this clinical trial?
"Affirmative. According to the clinicaltrials.gov website, this experiment is actively searching for 22 participants that can be found at a single site. The trial was initially posted on August 24th 2020 and has been recently updated as of February 1st 2022."
How many patients are being monitored as part of this medical trial?
"Affirmative. The information posted on clinicaltrials.gov shows that this investigation continues to recruit participants, as it was initially shared on August 24th 2020 and most recently revised on February 1st 2022. At present, the team is searching for 22 individuals at a single medical centre."
What additional investigations have been conducted concerning Methylphenidate?
"Currently, there are 29 studies actively researching Methylphenidate with two in the final stage of clinical trials. Most of these experiments take place in Lexington, Kentucky yet an additional 42 sites are running related research projects."
Has Methylphenidate been granted authorization by the FDA?
"Due to its status as a Phase 1 trial, with limited evidence for safety and efficacy, Methylphenidate has been given an estimated score of 1."
Who else is applying?
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What portion of applicants met pre-screening criteria?
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