Effect of Number of Remote Limb Ischemic Conditioning Cycles on Learning Enhancement

NCT03512041 | Completed Phase 1 Results DMC

• 2 other identifiers: NIHR01HD085930-Aim2R01HD085930
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to determine the effect of number of remote limb ischemic conditioning (RLIC) cycles on enhancing learning in neurologically intact young adults.

Conditions

Healthy, Young Adults

Keywords

ischemic conditioning, motor learning

Outcome Measures

Primary Outcomes (3)

• Balance Score

  The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant maintains the stability platform within ±3° of horizontal position during 5 trials of 30 seconds each. A greater increase in the balance score means more learning has occurred over the course of the study.

  Visit 1 and Visit 7, approximately 1 week

• Cup Stacking Score

  The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant takes to stack and unstack pre-determined patterns of cups. A greater decrease in the cup stacking score means more learning has occurred over the course of the study.

  Visit 1 and Visit 7, approximately 1 week

• Discrete Sequence Production Task Score

  The change from Visit 1 to Visit 7 in the average amount of time in seconds that a participant takes to complete pre-determined patterns of keypresses. A greater decrease in the Discrete Sequence Production Task score means more learning has occurred over the course of the study.

  Visit 1 and Visit 7, approximately 1 week

Study Arms (4)

RLIC - 5 Cycles

EXPERIMENTAL

Remote Limb Ischemic Conditioning (RLIC) is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the non-dominant arm. 5 Cycles of RLIC requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.

Behavioral: RLIC - 5 cycles; Behavioral: Balance training; Behavioral: Arm training; Behavioral: Sequence production training

RLIC - 4 Cycles

EXPERIMENTAL

RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the non-dominant arm. 4 Cycles of RLIC requires 35 minutes and involves 4 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.

Behavioral: RLIC - 4 Cycles; Behavioral: Balance training; Behavioral: Arm training; Behavioral: Sequence production training

RLIC - 3 Cycles

EXPERIMENTAL

RLIC is achieved via blood pressure cuff inflation to 20 mmHg above systolic blood pressure on the non-dominant arm. 3 Cycles of RLIC requires 25 minutes and involves 3 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. RLIC is performed on visits 1-7.

Behavioral: RLIC - 3 Cycles; Behavioral: Balance training; Behavioral: Arm training; Behavioral: Sequence production training

Sham Conditioning

SHAM COMPARATOR

Sham conditioning is achieved via blood pressure cuff inflation to 10 mmHg under diastolic blood pressure on the non-dominant arm. Sham conditioning requires 45 minutes and involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation. Sham conditioning is performed on visits 1-7.

Behavioral: Sham conditioning; Behavioral: Balance training; Behavioral: Arm training; Behavioral: Sequence production training

Interventions

RLIC - 5 cycles BEHAVIORAL

RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.

Also known as: Ischemic conditioning

RLIC - 5 Cycles

RLIC - 4 Cycles BEHAVIORAL

RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.

Also known as: Ischemic conditioning

RLIC - 4 Cycles

RLIC - 3 Cycles BEHAVIORAL

RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.

Also known as: Ischemic conditioning

RLIC - 3 Cycles

Sham conditioning BEHAVIORAL

Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays.

Sham Conditioning

Balance training BEHAVIORAL

All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.

RLIC - 3 Cycles; RLIC - 4 Cycles; RLIC - 5 Cycles; Sham Conditioning

Arm training BEHAVIORAL

All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.

Also known as: Cup stacking

RLIC - 3 Cycles; RLIC - 4 Cycles; RLIC - 5 Cycles; Sham Conditioning

Sequence production training BEHAVIORAL

All participants undergo training on a discrete sequence production task. Participants learn to associate specific color and shape symbols with sequences of key presses on a keyboard. Participants perform the sequence production task for 10-15 minutes per day at visits 3-7.

RLIC - 3 Cycles; RLIC - 4 Cycles; RLIC - 5 Cycles; Sham Conditioning

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Between the age of 18 and 40 years

You may not qualify if:

• History of neurological condition (i.e. stroke, Alzheimer's disease, Parkinson's disease), ADD, ADHD, balance impairment, or vestibular disorder
• History of sleep apnea
• History of lower extremity condition, injury, or surgery which could compromise performance on motor training task
• Any extremity soft tissue, orthopedic, or vascular injury (i.e. peripheral vascular disease) which may contraindicate RLIC
• Any cognitive, sensory, or communication problem that would prevent completion of the study
• Current intensive weight lifting or interval training exercise
• Current substance abuse or dependence
• Current use of medication with selective serotonin-reuptake inhibitors.
• Unwillingness to travel for all study visits

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Results Point of Contact

• Title: Catherine E Lang
• Organization: Washington University School of Medicine

langc@wustl.edu

314-286-1945

Study Officials

• Catherine Lang, PT, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be masked to their group assignment (RLIC or Sham conditioning) throughout the study. Participants will intuitively know the dose (number of cycles) of their assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Single blinded, randomized controlled trial

Study Record Dates

• First Submitted: April 18, 2018
• First Posted: April 30, 2018
• Study Start: December 13, 2016
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2018
• Last Updated: August 26, 2019
• Results First Posted: August 26, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication
• Access Criteria: Data will be available to anyone who wishes to access it through Washington University data repository.

Locations

US (1)