Activity-Dependent Transspinal Stimulation in SCI

NCT03669302 | Terminated FDA Device

• 1 other identifier: C33276GG
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Robotic gait training is often used with the aim to improve walking ability in individuals with Spinal Cord Injury. However, robotic gait training alone may not be sufficient. This study will compare the effects of robotic gait training alone to robotic gait training combined with either low-frequency or high-frequency non-invasive transspinal electrical stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of nerve function will be performed before and after 20 sessions of gait training with or without stimulation.

Conditions

Spinal Cord Injuries; Paraplegia, Spinal; Tetraplegia/Tetraparesis; Paraplegia, Spastic

Keywords

locomotor training; transcutaneous spinal cord stimulation; Lokomat; brain stimulation; peripheral nerve stimulation; H-reflex; spinal neural circuits; neuroplasticity; recovery

Outcome Measures

Primary Outcomes (2)

• Plasticity of cortical and corticospinal neuronal circuits

  Neurophysiological tests probing cortical and corticospinal excitability will be measured before and after the intervention. Single-pulse transcranial magnetic stimulation (TMS) will be used to assemble the recruitment curve of motor evoked potentials, and paired-pulse TMS will be used to probe changes in cortical inhibitory and facilitatory neuronal circuits.

  3 years

• Plasticity of spinal neuronal circuits

  Neurophysiological tests probing spinal reflex excitability will be measured before and after each intervention by posterior tibial and sural nerves stimulation during Lokomat-assisted stepping depicting the amplitude modulation of the soleus H-reflex and tibialis anterior flexor reflex.

  3 years

Secondary Outcomes (3)

• Senorimotor leg motor function

  3 years

• Spasticity

  3 years

• Walking function

  3 years

Study Arms (3)

Robotic gait training

SHAM COMPARATOR

Robotic gait training only

Other: Robotic gait training

Robotic gait training & low-frequeny transspinal stimulation.

EXPERIMENTAL

Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at low frequency (0.3 Hz).

Device: Robotic gait training and low-frequency transspinal stimulation

Robotic gait training & high-frequeny transspinal stimulation.

EXPERIMENTAL

Robotic gait training will be administered along with non-invasive transspinal stimulation over the thoracolumbar region during assisted stepping at high frequency (30 Hz).

Device: Robotic gait training and high-frequency transspinal stimulation

Interventions

Robotic gait training OTHER

Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

Robotic gait training

Robotic gait training and low-frequency transspinal stimulation DEVICE

Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a single pulse at 0.3 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

Robotic gait training & low-frequeny transspinal stimulation.

Robotic gait training and high-frequency transspinal stimulation DEVICE

Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.

Robotic gait training & high-frequeny transspinal stimulation.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of motor incomplete spinal cord injury (SCI).
• SCI is above thoracic 12 vertebra.
• Absent permanent ankle joint contractures.
• SCI occurred 6 months before enrollment to the study.

You may not qualify if:

• Supraspinal lesions
• Neuropathies of the peripheral nervous system
• Degenerative neurological disorders of the spine or spinal cord
• Motor complete SCI
• Presence of pressure sores
• Urinary tract infection
• Neoplastic or vascular disorders of the spine or spinal cord
• Pregnant women or women who suspect they may be or may become pregnant.
• People with cochlear implants, pacemaker and implanted stimulators
• People with history of seizures
• People with implanted Baclofen pumb

Sponsors & Collaborators

• City University of New York: lead
• Bronx Veterans Medical Research Foundation, Inc: collaborator

Study Sites (2)

Department of Physical Therapy, Motor Control and NeuroRecovery Laboratory

Staten Island, New York, 10314, United States

Location

Veterans Affairs Medical Center

The Bronx, New York, 10468, United States

Location

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MeSH Terms

Conditions

Spinal Cord Injuries; Paraplegia; Quadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Knikou, PT, PhD

  Research Foundation of the City University of New York

  PRINCIPAL INVESTIGATOR

• Noam Y Harel, MD, PhD

  VA Office of Research and Development

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Individuals with Spinal Cord Imjury will be randomly assigned to receive robotic gait training with the Lokomat, and/or Lokomat gait training combined with non-invasive thoracolumbar transspinal stimulation at 0.3 or at 30 Hz.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 13, 2018
• Study Start: August 1, 2018
• Primary Completion: October 1, 2021
• Study Completion: October 2, 2021
• Last Updated: August 10, 2022

Record last verified: 2022-08

Locations

US (2)