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Can ritalin Jump-Start the brain after a coma?

NCT ID NCT03814356

Disease control Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests whether a stimulant drug (methylphenidate, also known as Ritalin) given through an IV can safely help people with severe brain injuries regain consciousness. Ten adults in a coma or minimally conscious state will receive increasing doses to check for side effects like dangerous spikes in blood pressure or brain pressure. The study is too small to prove the drug works, but it lays the groundwork for future research.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
methylphenidate (Ritalin) given intravenously
What this could lead to
If safe and effective, this could point toward a treatment to help awaken patients with severe brain injuries.
What could go wrong
This is a very early Phase 1 safety study with only 10 participants, so it cannot prove the drug works. Risks include high blood pressure, fast heart rate, and increased brain pressure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

10 people

The number who actually took part.

Started

Aug 2020

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age ≥ 18 years 2. Severe, acute traumatic brain injury 3. Diagnosis of Coma, Vegetative State, or Minimally Conscious State Exclusion Criteria: 1. Penetrating brain injury caused by a metallic missile/object (e.g. bullet) 2. Body metal contraindicating MRI 3. Prisoner or ward of the state 4. Neurological 1. Bilateral dilated unresponsive pupils 2. 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) 3. Intracranial bolt 4. Status epilepticus or concern for post-ictal state 5. Cardiovascular 1. Poorly controlled hypertension (SBP \> 200 mmHg of DBP \> 120mmHg for 30 minutes, despite anti-hypertensive therapy, within the past 24 hours) 2. Coronary artery disease 3. ST elevation myocardial infarction 4. Acute coronary syndrome 5. Hemodynamically significant dysrhythmia 6. Congestive heart failure 7. Cardiomyopathy (including Takotsubo cardiomyopathy) 8. Other severe structural cardiac abnormalities 6. Renal a. Renal failure requiring renal replacement therapy (e.g. CVVH or HD) 7. Endocrine a. History of or clinical suspicion for thyrotoxicosis 8. Reproductive a. Pregnancy 9. Ophthalmologic a. History of glaucoma 10. Pharmacologic a. Monoamine oxidase inhibitor therapy within past 14 days 11. Other 1. 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

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia brain injury Coma Consciousness Disorders disease ocular motor apraxia, Cogan type traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anoxic brain injury Brain injury traumatic severe (diagnosis) COMA Consciousness, level altered

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

More trials for these conditions

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