Branched Chain Amino Acids for Traumatic Brain Injury

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Traumatic Brain InjuryBranched Chain Amino Acids - DietarySupplement
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new therapy consisting of dietary supplementation with branched chain amino acids (BCAA) to see if it can help improve sleep and cognition in Veterans with mTBI.

Eligible Conditions
  • Traumatic Brain Injury

Treatment Effectiveness

Study Objectives

23 Primary · 0 Secondary · Reporting Duration: Year 4

12 weeks
Change in Reasons for non-adherence
Patient satisfacetion with overall study process
Patient satisfaction with overall study process
4 weeks
Monitoring of Side Effects Scale (MOSES)
Reasons for non-adherence
8 weeks
Change in Monitoring of Side Effects Scale (MOSES)
Year 1
Study Drug Adherence by drug accounting
Study drug adherence by sleep diary
Year 2
Study Drug Adherence by serum assay
Study Drug Adherence by serum or sweat assay
Year 3
Study drug adherene by drug accounting
Year 4
Actiwatch Adherence
Incidence of non-participation
Primary
Recruitment
Recruitment source
Retention
Retention by arm
Screen Failures
Study Drug Adherence by sleep diary
Study drug adherence by drug accounting
Study drug adherence by serum assay
Study drug adherence by serum or sweat assay

Trial Safety

Trial Design

4 Treatment Groups

BCAA 20g/daily
1 of 4
BCAA 60 g/daily
1 of 4
BCAA 40g/daily
1 of 4
Placebo 60 g/daily
1 of 4

Experimental Treatment

Non-Treatment Group

200 Total Participants · 4 Treatment Groups

Primary Treatment: Branched Chain Amino Acids · Has Placebo Group · N/A

BCAA 20g/daily
DietarySupplement
Experimental Group · 1 Intervention: Branched Chain Amino Acids · Intervention Types: DietarySupplement
BCAA 60 g/daily
DietarySupplement
Experimental Group · 1 Intervention: Branched Chain Amino Acids · Intervention Types: DietarySupplement
BCAA 40g/daily
DietarySupplement
Experimental Group · 1 Intervention: Branched Chain Amino Acids · Intervention Types: DietarySupplement
Placebo 60 g/daily
DietarySupplement
PlaceboComparator Group · 1 Intervention: Protein Control · Intervention Types: DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Branched Chain Amino Acids
2019
N/A
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: year 4

Who is running the clinical trial?

Oregon Health and Science UniversityOTHER
894 Previous Clinical Trials
6,830,974 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
650 Previous Clinical Trials
7,849,369 Total Patients Enrolled
VA Office of Research and DevelopmentLead Sponsor
1,485 Previous Clinical Trials
2,742,078 Total Patients Enrolled
Miranda M Lim, MD PhDPrincipal InvestigatorVA Portland Health Care System, Portland, OR

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are not pregnant or are not likely to become pregnant during the study.
You have a phone.

Who else is applying?

What state do they live in?
Oregon100.0%
How old are they?
18 - 65100.0%
What site did they apply to?
VA Portland Health Care System, Portland, OR100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%