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Stimulant

Methylphenidate for Disorders of Consciousness (STIMPACT Trial)

Phase 1

Recruiting

Led By Brian L Edlow, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Severe, acute traumatic brain injury

Age ≥ 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 days

Awards & highlights

STIMPACT Trial Summary

This trial is testing the safety of giving methylphenidate to people with disorders of consciousness caused by severe brain injuries.

Who is the study for?

Adults with severe, acute traumatic brain injury in a coma, vegetative state, or minimally conscious state can join this trial. It's not for those with metallic brain injuries, metal that makes MRI unsafe, prisoners, certain neurological conditions like unresponsive pupils or high intracranial pressure, pregnancy, glaucoma history, recent monoamine oxidase inhibitor therapy or serious cardiovascular and renal issues.Check my eligibility

What is being tested?

The STIMPACT trial is testing the safety of different doses of IV methylphenidate (MPH) to see if it helps reactivate consciousness in patients with disorders of consciousness due to severe brain injuries. The study will increase MPH doses unless side effects occur and will monitor its effects using EEG and MRI measures.See study design

What are the potential side effects?

Possible side effects include reactions related to dose levels such as increased blood pressure or heart rate problems. Since it's an open-label safety study focusing on dosage tolerance, specific side effect details may emerge from the trial observations.

STIMPACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a severe brain injury from a recent accident.

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I am 18 years old or older.

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I am diagnosed with a severe consciousness disorder.

STIMPACT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adverse Events

Secondary outcome measures

Cerebral Cortical Connectivity as Measured by EEG

Cerebral Cortical Connectivity as Measured by fMRI

Maximal Serum Concentration

+1 more

Side effects data

From 2020 Phase 4 trial • 267 Patients • NCT02039908

51%

Appetite Loss

40%

Insomnia

33%

Irritability

29%

Picking at skin, nailbiting

21%

Worried/Anxious

21%

Dull, tired, listless

19%

Tearful, depressed

18%

Stomachache

13%

Headache

13%

Motor Tics

12%

Buccal-lingual movements

10%

Social Withdrawal

Hospitalized

100%

80%

60%

40%

20%

Study treatment Arm

Phase 1-Medication First

Phase 1 - Placebo First

Phase 2 - 7-Day Dosing

Phase 2 - 5-Day Dosing

STIMPACT Trial Design

1Treatment groups

Experimental Treatment

Group I: IV MPHExperimental Treatment1 Intervention

All patients will receive IV Methylphenidate (MPH). Patients will receive escalating daily doses of IV MPH starting at 0.5 mg/kg, increasing stepwise to 1.0mg/kg and 2.0 mg/kg unless an adverse event (AE) necessitates dose de-escalation or a serious adverse event (SAE) necessitates that the patient stop participation in the study.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylphenidate

2014

Completed Phase 4

~431850

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,333 Total Patients Enrolled

1 Trials studying Altered Level of Consciousness

12 Patients Enrolled for Altered Level of Consciousness

Brian L Edlow, MDPrincipal InvestigatorMassachusetts General Hospital

1 Previous Clinical Trials

50 Total Patients Enrolled

Media Library

Methylphenidate (Stimulant) Clinical Trial Eligibility Overview. Trial Name: NCT03814356 — Phase 1

Altered Level of Consciousness Research Study Groups: IV MPH

Altered Level of Consciousness Clinical Trial 2023: Methylphenidate Highlights & Side Effects. Trial Name: NCT03814356 — Phase 1

Methylphenidate (Stimulant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03814356 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI