Methylphenidate for Semiconsciousness

Phase-Based Estimates
1
Effectiveness
1
Safety
Massachusetts General Hospital, Boston, MA
Semiconsciousness+7 More
Methylphenidate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Semiconsciousness

Study Summary

This study is evaluating whether a drug may help improve consciousness for individuals with disorders of consciousness.

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Eligible Conditions

  • Semiconsciousness
  • Consciousness Disorders
  • Wounds
  • Brain Injuries
  • Coma
  • Brain Injuries, Traumatic
  • Wounds and Injuries
  • Brain Injury Traumatic Severe (Diagnosis)
  • Anoxic Brain Injury
  • Altered Level of Consciousness

Treatment Effectiveness

Effectiveness Estimate

1 of 3

Study Objectives

This trial is evaluating whether Methylphenidate will improve 1 primary outcome and 4 secondary outcomes in patients with Semiconsciousness. Measurement will happen over the course of 4 Days.

4 Days
Adverse Events
Cerebral Cortical Connectivity as Measured by EEG
Cerebral Cortical Connectivity as Measured by fMRI
Maximal Serum Concentration
Serum Half-life

Trial Safety

Side Effects for

Phase 2 - 7-Day Dosing
Appetite Loss
38%
Insomnia
38%
Irritability
31%
Picking at skin, nailbiting
31%
Worried/Anxious
21%
Stomachache
17%
Motor Tics
14%
Dull, tired, listless
12%
Headache
12%
Tearful, depressed
12%
Buccal-lingual movements
8%
Social Withdrawal
4%
Hospitalized
1%
This histogram enumerates side effects from a completed 2020 Phase 4 trial (NCT02039908) in the Phase 2 - 7-Day Dosing ARM group. Side effects include: Appetite Loss with 38%, Insomnia with 38%, Irritability with 31%, Picking at skin, nailbiting with 31%, Worried/Anxious with 21%.

Trial Design

2 Treatment Groups

Control
IV MPH

This trial requires 22 total participants across 2 different treatment groups

This trial involves 2 different treatments. Methylphenidate is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

IV MPH
Drug
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.
ControlNo treatment in the control group
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylphenidate
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 4 days
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly 4 days for reporting.

Who is running the study

Principal Investigator
B. L. E. M.
Brian L. Edlow M.D., Director, Laboratory for NeuroImaging of Coma and Consciousness (NICC)
Massachusetts General Hospital

Closest Location

Massachusetts General Hospital - Boston, MA

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 3 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Age ≥ 18 years
Severe, acute traumatic brain injury
If you are wondering if someone you know is in a coma, vegetative state, or minimally conscious state, it can be difficult to tell show original

Patient Q&A Section

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

How does methylphenidate work?

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The positive results of the present study can be explained by the fact that the drug seems able to activate different dopaminergic pathways in different brain regions, affecting both reward and response inhibition, thus potentially producing a dissociative-stimulative effect and increasing the ability to respond to reward and to override impulse.

Unverified Answer

What is semiconsciousness?

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Segmented general anesthetic and surgical anesthesia often causes transient loss of consciousness. The patient might be awakened and return to consciousness spontaneously after the surgery. It has a characteristic pattern: a rapid loss of awareness, followed by abrupt return to consciousness. This phenomenon is called'semiconsciousness'. Because of this, it is important to determine and maintain the patient's level of consciousness when using this type of anesthesia.

Unverified Answer

Can semiconsciousness be cured?

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Semiconsciousness can be cured although it does not appear to remit or be amenable to treatment. The clinical utility and significance of this finding are undetermined as the study did not determine the time of onset of the episode.

Unverified Answer

What are common treatments for semiconsciousness?

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Although research continues, no single treatment has been shown to be effective in most patients with posttraumatic recovery of consciousness. Treatment options often include a combination of pharmacologic and nonpharmacologic approaches. Future research should include additional randomized controlled trials to determine whether a specific approach proves more effective in clinical practice.

Unverified Answer

How many people get semiconsciousness a year in the United States?

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About 5,000 people in the United States get semiconsciousness a year. This is about half what the American Thoracic Society estimates for a minimum of 30,000 people with semiconsciousness in all of the United States per year. semiconsciousness is underreported.

Unverified Answer

What are the signs of semiconsciousness?

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Semiconsciousness can be caused by many neurologic problems such as cerebral hypoxia after stroke, encephalitis, or by drugs. Differential diagnosis is important; the symptoms are not unique to one entity. The differential diagnosis includes seizures, drug intoxication, seizure-related syncope, intracranial and extracranial diseases, cerebral or spinal stenosis, subdural hematoma, hypoxia, hypoglycaemia, hypothermia, cardiopulmonary disease, metabolic disorders, or other neurological disorders. Semiconsciousness typically is a marker or first indication of a serious neurological problem and the underlying cause of the semiconsciousness should be sought and promptly managed.

Unverified Answer

What causes semiconsciousness?

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Semiconscious patients who have undergone brain surgery are at a lower risk of developing symptoms of postoperative delirium or postoperative psychosis than their counterparts without surgery. The occurrence of postoperative delirium and postoperative psychosis is associated with postoperative encephalopathy before surgery as well as impaired cerebral hemodynamic recovery on POD2. The incidence of delirium and psychosis after cerebral surgery is low (12%), although high numbers of patients have to be evaluated for this problem.

Unverified Answer

Is methylphenidate safe for people?

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These data strongly suggest that methylphenidate appears to be safe, and the risk-benefit ratio appears to be very high. The safety of long-term methylphenidate continued use appears to be acceptable, provided a very close monitoring system is set-up.

Unverified Answer

Have there been other clinical trials involving methylphenidate?

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There have been a few clinical trials involving methylphenidate. In order to make better decisions about methylphenidate, we must conduct additional trials, and review previous clinical trials with larger sample sizes.

Unverified Answer

Have there been any new discoveries for treating semiconsciousness?

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There are many factors that cause people to become conscious. Among the important things to know about semiconsciousness are how much consciousness is needed to be able to live a normal life; how much consciousness is normal; and which diseases are responsible for this state. A lack of sleep or a poor diet can be very much responsible for getting into semiconsciousness and keeping it there. If you are in semiconsconsciousness or experiencing semiconsciousness, and you have a family member in real life or even one person in your dreams, you should see a medical doctor. Semiconsconsciousness can also be caused by brain damage, stroke, or other traumatic events.

Unverified Answer

Who should consider clinical trials for semiconsciousness?

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Given these data from a national survey, we recommend that clinical trials including semiconsciousness should include patients who can give informed consent, which is achievable by asking them to use a proxy for the patient. Although semiconsciousness can be experienced at any time, clinical trials are most likely to be informative in the first six months of the illness. Clinical trials using a standard control group such as placebo or the comparator-based method of random allocation may be helpful to determine whether intervention improves outcomes over baseline.

Unverified Answer

What is the latest research for semiconsciousness?

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There is more research now in the field of semiconsciousness but the information is not consistent. It is unclear if the condition has or does not have one of the symptoms associated with it. There are no tests to prove semiconsciousness and treatment is not available. More research is needed in this area of consciousness and consciousness is a new area of study. Semiconsciousness should be taken seriously because it would be difficult to treat.

Unverified Answer
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