Remote Ischemic Conditioning and Spinal Reflex Modulation

NCT06860464 | Enrolling By Invitation DMC

• 1 other identifier: UMCIRB 23-001021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Remote ischemic conditioning (RIC) is a clinically feasible method that protects distant organs from severe injury through brief, sub lethal periods of ischemia followed by re-perfusion. Recent studies suggest that RIC, combined with training, improves muscle strength and balance in healthy adults and post-stroke survivors. While the underlying mechanisms are not fully understood, RIC's neuroprotective effects - such as promoting angiogenesis, neurogenesis, and modulating glutamate and GABA synthesis - overlap with neuroplasticity processes. Evidence indicates that neuroplasticity from exercise training occurs not only in the cerebral cortex but also within the spinal cord, yet the role of spinal reflex mechanisms underlying the benefits of RIC remains under explored. Therefore, this study aims to investigate effects of RIC on spinal reflex modulation in healthy adults, both independently and combined with balance training.

Conditions

Healthy Young Adults

Keywords

Remote ischemic conditioning; Spinal reflex modulation; H-reflex; Balance training

Outcome Measures

Primary Outcomes (2)

• Change in maximal H-reflex amplitude (Hmax)

  The maximal (peak) H-reflex amplitude will be determined from the recruitment (stimulus-response) curve. The Hmax amplitude provides an estimate of the number or proportion of motor neurons (MNs) activated from the total MN pool, reflecting spinal reflex modulations and spinal neuroplasticity.

  Baseline, Day 7

• Change in Hmax/ Mmax Ratio

  The maximal H-reflex and maximal M-wave amplitudes will be determined from the recruitment curve procedure. Calculating the Hmax/Mmax ratio is a standardization method used to reduce variability in H-reflex amplitude across participants. This provides a better basis for comparison and a more reliable estimate of changes in spinal reflex modulations between participants.

  Baseline, Day 7

Secondary Outcomes (1)

• Change in Balance Performance

  Baseline, Day 7

Study Arms (2)

Remote Ischemic Conditioning (RIC)

EXPERIMENTAL

RIC is achieved via blood pressure cuff inflation to at least 20 mmHg above systolic blood pressure to 250 mmHg on the thigh of dominant LE. RIC involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. RIC is performed on visits 2 - 6.

Behavioral: Remote Ischemic Condtioning (RIC); Behavioral: Balance training

Sham conditioning

SHAM COMPARATOR

Sham conditioning is achieved via blood pressure cuff inflation to 25 mm Hg on the thigh of the dominant LE. Sham involves 5 cycles of 5 minutes blood pressure cuff inflation followed by alternating 5 minutes of cuff deflation and requires 45 minutes. Sham conditioning is performed on visits 2-6.

Behavioral: Sham Conditioning; Behavioral: Balance training

Interventions

Remote Ischemic Condtioning (RIC) BEHAVIORAL

See descriptions under arm/group descriptions. RIC is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, and visits 2-6 are RIC plus training visits.

Remote Ischemic Conditioning (RIC)

Sham Conditioning BEHAVIORAL

See descriptions under arm/group descriptions. Sham conditioning is delivered for 5 intervention visits. Visits 1 is the baseline assessment visit, and visits 2-6 are Sham plus training visits.

Sham conditioning

Balance training BEHAVIORAL

All participants will undergo training on a balance board, learning to hold the board level within the 5- degree horizontal range. Participants perform the balance task for 15, 30-second trials per day at visits 2-6.

Remote Ischemic Conditioning (RIC); Sham conditioning

Eligibility Criteria

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

You may qualify if:

• Healthy adults 18-40 years of age

You may not qualify if:

• Individuals with cognitive deficits or communication problems
• Individuals with impaired vision
• Individuals with balance disorders such as vestibular disorders, etc.
• Individuals who are pregnant
• Individuals with known cardiorespiratory dysfunctions
• Presence of lower extremity condition, injury, or surgery within last three months which could compromise training

Sponsors & Collaborators

• East Carolina University: lead

Study Sites (1)

Swati Surkar

Greenville, North Carolina, 27858-6055, United States

Location

Related Publications (5)

• Taube W, Kullmann N, Leukel C, Kurz O, Amtage F, Gollhofer A. Differential reflex adaptations following sensorimotor and strength training in young elite athletes. Int J Sports Med. 2007 Dec;28(12):999-1005. doi: 10.1055/s-2007-964996. Epub 2007 May 11.

  PMID: 17497570 BACKGROUND

• Quadrado IC, Cancio RB, Silva BM, Vianna LC, Mezzarane RA. Modulation of spinal cord excitability following remote limb ischemic preconditioning in healthy young men. Exp Brain Res. 2020 May;238(5):1265-1276. doi: 10.1007/s00221-020-05807-w. Epub 2020 Apr 17.

  PMID: 32303809 BACKGROUND

• Surkar SM, Bland MD, Mattlage AE, Chen L, Gidday JM, Lee JM, Hershey T, Lang CE. Effects of remote limb ischemic conditioning on muscle strength in healthy young adults: A randomized controlled trial. PLoS One. 2020 Feb 4;15(2):e0227263. doi: 10.1371/journal.pone.0227263. eCollection 2020.

  PMID: 32017777 BACKGROUND

• Dirnagl U, Becker K, Meisel A. Preconditioning and tolerance against cerebral ischaemia: from experimental strategies to clinical use. Lancet Neurol. 2009 Apr;8(4):398-412. doi: 10.1016/S1474-4422(09)70054-7.

  PMID: 19296922 BACKGROUND

• Kharbanda RK, Nielsen TT, Redington AN. Translation of remote ischaemic preconditioning into clinical practice. Lancet. 2009 Oct 31;374(9700):1557-65. doi: 10.1016/S0140-6736(09)61421-5.

  PMID: 19880021 BACKGROUND

Study Officials

• Swati M Surkar, PT, PhD

  East Carolina University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are masked to group assignment (RLIC vs. Sham conditioning)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: March 6, 2025
• Study Start: March 6, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: After publishing the results of the study
• Access Criteria: Data will be made available upon request to the principal investigator.

Locations

US (1)