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Remote Ischemic Conditioning for Traumatic Brain Injury (MOTION Trial)

N/A
Recruiting
Led By Bellal Joseph, MD
Research Sponsored by University of Arizona
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of traumatic brain injury.
Glasgow Coma Scale (GCS) ≤13
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards
Awards & highlights

MOTION Trial Summary

This trial will study the effects of remote ischemic conditioning (RIC) on long-term outcomes in patients with traumatic brain injury (TBI).

Eligible Conditions
  • Traumatic Brain Injury

MOTION Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You have had a head injury.
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You have a severe brain injury with a Glasgow Coma Scale (GCS) score of 13 or less.

MOTION Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards
This trial's timeline: 3 weeks for screening, Varies for treatment, and before randomization, 6 hours post randomization, 24 hours post randomization, once daily during the patients' length of stay up to a maximum of 7 days afterwards for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Level of cardiac biomarker: Creatine Kinase MB CKMB (ug/ml)
Change in the Level of cardiac biomarker: Creatinine Phosphokinase (ug/ml)
Change in the Level of cardiac biomarker: Troponin c (ng/ml)
+3 more
Secondary outcome measures
Discharge Disposition/Destination
Glasgow Coma Scale (points)
Glasgow Outcome Scale-Extended (points)
+1 more

MOTION Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Remote Ischemic ConditioningExperimental Treatment1 Intervention
Remote ischemic conditioning will be performed using a standard manual blood pressure cuff. The pressure in the blood pressure cuff will be maintained at 30 mm of Hg higher than the patient's systolic blood pressure. 4 cycles of ischemic conditioning will be performed each day for a period of 7 days. Each cycle consists of 5 min of controlled upper limb ischemia (cuff up) followed by 5 min of reperfusion (cuff down). The total duration of the treatment cycle will be 40 min. The study protocol is based on our published literature in traumatic brain injury. Blood samples will be collected at 0 hours (before randomization). Then the first 4 cycles of RIC (done consecutively) will be performed, blood samples will be taken at 6 hours post randomization and then at 24 hours post randomization. RIC cycles will then be performed on a daily basis followed by taking a blood sample once daily during the patients' length of stay up to a maximum of 7 days
Group II: No Remote Ischemic ConditioningPlacebo Group1 Intervention
Blood samples will be collected at 0 hours (before randomization). Blood samples will then be collected at 6 hours post randomization and 24 hours post randomization. These patients will not receive daily RIC therapy but will only have their blood drawn once daily during the patients' length of stay up to a maximum of 7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Remote Ischemic Conditioning
2022
Completed Phase 3
~1820

Find a Location

Who is running the clinical trial?

University of ArizonaLead Sponsor
511 Previous Clinical Trials
148,168 Total Patients Enrolled
Bellal Joseph, MDPrincipal InvestigatorUniversity of Arizona
2 Previous Clinical Trials
370 Total Patients Enrolled

Frequently Asked Questions

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

Is this research experiment open to recruitment at the moment?

"Per the information available on clinicaltrials.gov, this scientific endeavour is actively searching for participants. The initial publishing date was September 24th 2019 and the latest edit occured May 23rd 2022."

Answered by AI

How many patients are taking part in this clinical research?

"Affirmative. The information on clinicaltrials.gov verify that this medical trial is actively looking for participants, which began the recruitment process back in September 2019 and was last updated on May 23rd 2022. Currently, 120 individuals need to be enrolled from a single site of treatment."

Answered by AI
Recent research and studies
~22 spots leftby Mar 2025