A Novel Repetitive Synchronized Associative Stimulation Neuromodulation Approach for Spinal Cord Injury Patients

Part of paid clinical trials in Miami, Florida.

Sponsor
University of Miami
Study ID
NCT06494059
Status
Recruiting
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Conditions

  • SCI - Spinal Cord Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Intermittent theta burst stimulation (iTBS) — OTHER
    iTBS is a magnetic stimulation applied using a magnetic coil that is placed on top of the participants head to activate the brain. It consists of three very rapid bursts of electrical pulses at a frequency of 50 Hz (per burst) delivered at a rate of 5 per second for 2 seconds (10 bursts). The burst of pulses will be repeated every 10 seconds for a total duration of about 3 minutes. The stimulation will be applied to activate the brain regions that control upper limb, lower limb or trunk muscles. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
  • Functional electrical stimulation (FES) — OTHER
    FES is applied using electrodes that stick to the skin over the muscles or nerves. It will will be applied using an electrical stimulator to produce movements of the hand, leg or the trunk. The stimulation intensity will be determined by gradually increasing strength from 20-100 hertz (hz) until the right amount of movement is obtained. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
  • Transcutaneous spinal cord stimulation (TSCS) — OTHER
    TSCS is applied using electrodes that stick to the skin over the spinal cord to activate spinal cord. Mild electrical stimulation will be applied to make sure the nerves on the back are activated (switched on). Different stimulation intensities (strength) will be tested at different frequencies (pulses per second) to determine the best setting for activating the nerves on the back. The stimulus current strength will be adjusted between 0-250 milliamperes (mA) and will remain within the self-reported tolerance limit of each participant. Each subject is expected to participate longitudinally at least 9 times over 2 months. Each visit will take approximately 2-3 hours.
  • Sham Intermittent theta burst stimulation (iTBS) — OTHER
    Subjects will be fitted with a magnetic coil that is placed on top of the head that does not deliver any stimulation to the brain. Each subject is expected to participate longitudinally at least 9 times over 2 months.Each visit will take approximately 2-3 hours.

Study Details

The purpose of this research is to explore the effect of magnetic stimulation to activate the brain, electrical spinal cord stimulation to activate spinal cord, and electrical muscle stimulation used to activate upper limb (arms), lower limb (legs) and trunk (stomach) muscles in people with spinal cord injury (SCI) and able-bodied subjects (without SCI).

Key Dates

Start date
Nov 4, 2024
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Upper-limb (arms) target group
    Quadriplegic individuals with SCI who are primary non-ambulatory (walking) will be in this group for up to 2 months.
  • Experimental: Lower-limb (legs) target group
    Quadriplegic or paraplegic individuals with SCI primary who can walk will be in this group for up to 2 months.
  • Experimental: Trunk (torso) target group
    Quadriplegic or paraplegic individuals with SCI who are primary wheelchair users will be in this group for up to 2 months.
  • Active Comparator: Able-bodied target group
    Individuals with no spinal cord injury will be in this group for up to 2 months.

Primary Outcome Measure

Change in nine-hole peg test [ Time Frame: baseline, up to 2 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida33136
Deena Cilien, DPT
[email protected]
305-243-9301
Matija Milosevic, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Miami· Miami, FL

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