SNPMiner Trials by Shray Alag

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SNPMiner SNPMiner Trials (Home Page)


Report for SNP rs333

Developed by Shray Alag, 2020-2021.
SNP Clinical Trial Gene

There is one clinical trial.

Clinical Trials


1 Maraviroc to Augment Rehabilitation Outcomes After Stroke

After stroke, the combination of progressive skills practice in an adequate dose, exercise for fitness, and reduced sedentary time will augment motor and cognitive outcomes. Sensorimotor and cognitive improvements after stroke often reach a general plateau by approximately 12 weeks after onset, however. Drugs that might enhance learning or neural repair, as well as other molecular and synaptic adaptations that occur during skills training and fitness exercise, might extend that recovery curve, although to date only fluoxetine has given any hint of this. Most trials have tested agents that modulate neurotransmitters. Several very recent preclinical experiments and observational studies in patients after stroke suggest that the commercially available medication, Maraviroc, a CCR5 antagonist, may augment skills learning during rehabilitation training, especially during the first three months after onset, by affecting CREB and synaptic plasticity. The investigators will carry out a randomized controlled trial of Maraviroc in patients with disabilities severe enough to have required inpatient stroke rehabilitation and, based on our preclinical data, who can start the drug intervention within 6 weeks of stroke onset. The investigators will compare usual post-stroke care plus placebo versus Maraviroc given for 8 weeks in 60 participants. However, to try to maximize the amount of practice that is most relevant to the primary outcome measurements and determine whether or not Maraviroc can enhance the effects of training, as hypothesized, all participants will be tele-monitored by mobile health devices and will receive weekly telephonic encouragement, based on device data, to walk, reduce sedentary time, and reach and grasp in the home in between usual care therapies. Compliance, serial motor changes over time, and self-management skills in making use of the telerehabilitation devices will be a nested substudy of feasibility of remote monitoring and feedback.

NCT03172026
Conditions
  1. Stroke
Interventions
  1. Drug: Maraviroc 300 mg
  2. Behavioral: Rehabilitation therapy
  3. Drug: Placebo 300 mg
MeSH:Stroke
HPO:Stroke

About 15% of the Ashkenazi Jewish population carries the deletion (CCR5 rs333 - 32).

Primary Outcomes

Description: Timed walking speed over 10 meters. The evaluable sample size of 30 in each group will have 80% power to detect a difference in means of -0.206 (m/s), the difference between an assumed usual care walking speed of 0.51 (SD=0.28) and an assumed intervention group mean walking speed of 0.716. This assumes a common standard deviation in the two groups and a two group t-test with a 0.05 two-sided significance level. The estimates for the mean and standard deviation for walking speed come from the LEAPS RCT (Duncan, N Engl J Med, 2011). The t-test used for the power calculation is a simplification of the mixed effects analysis plan for the primary endpoints.

Measure: 10 Meter Walk Test

Time: Baseline, 6 months post

Description: Assessment of upper extremity function. Our sample size of 30 for each group is based on a statistical power of 80% with an alpha of 5% for detecting a meaningful difference of 6 points, i.e., a 10% change, which has been suggested by several completed trials. In a stroke trial, the standard deviation was 8 points measured at 2 weeks post stroke.

Measure: Action Research Arm Test

Time: Baseline, 6 months post

Secondary Outcomes

Description: Assessment of arm and leg impairment after stroke

Measure: Fugl-Meyer Motor score

Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke

Description: Self-report questionnaire on quality of life post-stroke

Measure: Stroke Impact Scale

Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke

Description: Distance walked in a 6 minute time period

Measure: 6 minute walking distance

Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke

Description: Self-report questionnaire related to exercise enjoyment

Measure: Physical Activity Enjoyment Scale

Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke

Description: Self-report questionnaire related to confidence in increasing activity and maintaining exercise routines

Measure: Activity Self Efficacy

Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke

Description: Self-report of activity levels

Measure: International Physical Activity Questionnaire

Time: Baseline, within 5 days of last medication dose (8 weeks), at 6 months post stroke

Description: Sedentary time

Measure: Walking activity, Sensors

Time: Collected daily for 8 weeks

Description: Amount of time practicing

Measure: Upper extremity practice, Sensors

Time: Collected daily for 8 weeks

Description: Repetitions of task practice

Measure: Upper extremity practice, Sensors

Time: Collected daily for 8 weeks


HPO Nodes