Trial · NCT03814356
Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
NCT03814356, Phase 1, Active not recruiting, Massachusetts General Hospital; results first posted 2025-10-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness. Trials, record NCT03814356. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03814356
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Stimulant Therapy Targeted to Individualized Connectivity Maps to Promote ReACTivation of Consciousness
- NCT number
- NCT03814356
- Status
- Active not recruiting
- Phases
- Phase 1
- Enrollment
- 10 participants, actual
- Lead sponsor
- Massachusetts General Hospital
- Conditions
- Brain Injury Traumatic Severe (Diagnosis), Coma, Consciousness, Level Altered, Anoxic Brain Injury
- Interventions
- Methylphenidate
- First posted
- 2019-01-24
- Last updated
- 2025-10-29
- Results first posted
- 2025-10-29
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Adverse Events at Each Dose | 4 Days | 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 \> 25 mmHg for \> 5 min, refractory to medical therapy Serious Adverse Events An AE or suspected adverse reaction is considered "serious" if, in the view of the investigator or the Independent Medical Monitor, it results in any of the following outcomes: * Death not related to withdrawal of life-sustaining therapy * A life-threatening event * Prolongation of existing hospitalization * Significant incapacity or substantial disruption of the ability to conduct normal life function |
| Secondary | Time to Maximal Serum Concentration of IV Methylphenidate (MPH) | 4 Days | The median (range) time (hours) to maximum concentrations at 0.5, 1.0, and 2.0 mg/kg doses was measured. |
| Secondary | Serum Half-life of IV Methylphenidate (MPH) | 4 Days | The mean (SD) serum half-lives (hours) at 0.5, 1.0, and 2.0 mg/kg doses was assessed. |
| Secondary | Cerebral Cortical Connectivity as Measured by fMRI | 4 Days | We performed a change-point analysis of time-series resting-state fMRI data to determine if individual participants responded to the 2.0 mg/kg dose of IV MPH. Specifically, we measured resting-state fMRI connectivity between the brainstem ventral tegmental area and the default mode network after the bolus of IV MPH as compared to before the bolus of IV MPH. The bolus of IV MPH was administered in the MRI scanner while the patient was undergoing a 40-minute resting-state fMRI (10 minutes of data acquisition pre-bolus, 30 minutes of data acquisition post-bolus). The goal of the analysis was to determine if each patient responded to IV MPH, as defined by a positive change point (i.e., increase in connectivity after the bolus of IV MPH). Connectivity was measured via Pearson correlations using the software package CONN. |
| Secondary | Cerebral Cortical Connectivity as Measured by EEG | 4 Days | We performed a change-point analysis of time-series resting-state EEG data to determine if individual participants responded to each dose of IV MPH. Specifically, we measured resting-state EEG background rhythm, using the alpha/delta ratio as a quantitative biomarker of overall brain function (i.e., alpha/delta ratio was measured for all EEG leads in a clinical 19-electrode montage). In a continuous time-series analysis of resting EEG data acquired 1 hour before and 1 hour after each IV MPH bolus, we tested for a "change-point" in the alpha/delta ratio, which represents a statistically significant increase in alpha/delta ratio. The goal of the analysis was to determine if each patient responded to IV MPH, as defined by a positive change point (i.e., increase in alpha/delta after the bolus of IV MPH). EEG analyses were performed using MATLAB software. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events at Each Dose | 4 Days | 9 participants received the 0.5 mg/kg IV MPH dose and and the 1.0 mg/kg IV MPH dose. 6 participants received the 2.0 mg/kg IV MPH dose. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to Maximal Serum Concentration of IV Methylphenidate (MPH) | 4 Days | We measured the median (range) time (hours) to maximum concentrations at 0.5, 1.0, and 2.0 mg/kg doses of IV MPH. | hours | MEDIAN |
| SECONDARY | Serum Half-life of IV Methylphenidate (MPH) | 4 Days | The mean (SD) serum half-lives (hours) at 0.5, 1.0, and 2.0 mg/kg doses was assessed. | hours | MEAN |
| SECONDARY | Cerebral Cortical Connectivity as Measured by fMRI | 4 Days | Functional MRI data were obtained in two study participants. | number of responders | NUMBER |
| SECONDARY | Cerebral Cortical Connectivity as Measured by EEG | 4 Days | EEG data were obtained in all nine study participants at the 0.5 mg/kg dose and 1.0 mg/kg dose, and in 6 participants at the 2.0 mg/kg dose. | number of responders | NUMBER |
Source ClinicalTrials.gov
Results by group13
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Adverse Events at Each Dose | IV MPH | 0.5 mg/kg IV MPH | 0 | Participants | |
| Number of Participants With Adverse Events at Each Dose | IV MPH | 1.0 mg/kg IV MPH | 2 | Participants | |
| Number of Participants With Adverse Events at Each Dose | IV MPH | 2.0 mg/kg IV MPH | 1 | Participants | |
| Time to Maximal Serum Concentration of IV Methylphenidate (MPH) | IV MPH | 0.5 mg/kg IV MPH | 0.12 | Full Range 0.08 to 0.13 | hours |
| Time to Maximal Serum Concentration of IV Methylphenidate (MPH) | IV MPH | 1.0 mg/kg IV MPH | 0.15 | Full Range 0.07 to 0.18 | hours |
| Time to Maximal Serum Concentration of IV Methylphenidate (MPH) | IV MPH | 2.0 mg/kg IV MPH | 0.23 | Full Range 0.2 to 0.3 | hours |
| Serum Half-life of IV Methylphenidate (MPH) | IV MPH | 0.5 mg/kg | 5.07 | Standard Deviation 2.55 | hours |
| Serum Half-life of IV Methylphenidate (MPH) | IV MPH | 1.0 mg/kg | 4.39 | Standard Deviation 1.92 | hours |
| Serum Half-life of IV Methylphenidate (MPH) | IV MPH | 2.0 mg/kg | 5.01 | Standard Deviation 1.80 | hours |
| Cerebral Cortical Connectivity as Measured by fMRI | IV MPH | 1 | number of responders |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | IV MPH | 9 | |
| Overall Study | COMPLETED | IV MPH | 9 | |
| Overall Study | NOT COMPLETED | IV MPH | 0 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Paroxysmal Sympathetic Hyperactivity | Nervous system disorders | 0.5 mg/kg IV MPH | 0 | 9 | 0 |
| other | Paroxysmal Sympathetic Hyperactivity | Nervous system disorders | 1.0 mg/kg IV MPH | 1 | 9 | 1 |
| other | Paroxysmal Sympathetic Hyperactivity | Nervous system disorders | 2.0 mg/kg IV MPH | 0 | 6 | 0 |
| other | Insomnia | Nervous system disorders | 0.5 mg/kg IV MPH | 0 | 9 | 0 |
| other | Insomnia | Nervous system disorders | 1.0 mg/kg IV MPH | 1 | 9 | 1 |
| other | Insomnia | Nervous system disorders | 2.0 mg/kg IV MPH | 0 | 6 | 0 |
| other | Emesis | Gastrointestinal disorders | 0.5 mg/kg IV MPH | 0 | 9 | 0 |
| other | Emesis | Gastrointestinal disorders | 1.0 mg/kg IV MPH | 1 | 9 | 1 |
| other | Emesis | Gastrointestinal disorders | 2.0 mg/kg IV MPH | 0 | 6 | 0 |
| other | Transaminitis (increased ALT/AST) | Hepatobiliary disorders | 0.5 mg/kg IV MPH | 0 | 9 | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 0.5 mg/kg IV MPH | 0 | 9 |
| Total, all-cause mortality | 1.0 mg/kg IV MPH | 0 | 9 |
| Total, all-cause mortality | 2.0 mg/kg IV MPH | 0 | 6 |
| Total, other adverse events | 0.5 mg/kg IV MPH | 0 | 9 |
| Total, other adverse events | 1.0 mg/kg IV MPH | 2 | 9 |
| Total, other adverse events | 2.0 mg/kg IV MPH | 1 | 6 |
| Total, serious adverse events | 0.5 mg/kg IV MPH | 0 | 9 |
| Total, serious adverse events | 1.0 mg/kg IV MPH | 0 | 9 |
| Total, serious adverse events | 2.0 mg/kg IV MPH | 0 | 6 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32794142 | BACKGROUND |
Source PubMed
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| DP2HD101400 | A Connectome-Based Clinical Trial Platform to Promote Early Recovery of Consciousness after Traumatic Coma | EDLOW, BRIAN L. | MASSACHUSETTS GENERAL HOSPITAL | EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH & HUMAN DEVELOPMENT | 2019 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03814356
GET https://conductscience.org/api/trials/v1/NCT03814356/registered