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Completed

NCT Number: NCT03277521

Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia

A repetitive, non-invasive brain stimulation technique referred to as theta burst stimulation can modulate corticomotor excitability and therefore has great rehabilitative potential for individuals with neurologic deficits, including individuals with spinal cord injury (SCI). In particular, intermittent theta burst stimulation (iTBS) can increase corticomotor excitability and may be a useful adjunct to physical rehabilitation to promote motor re-education after upper limb reconstruction in individuals with tetraplegia. Upper limb reconstruction involves surgical transfer of a non-paralyzed tendon or nerve with a redundant or less important function to perform a more critical function. Upper limb reconstruction is intended to help individuals achieve their goals related to activities of daily living and independence in the community. Outcomes after reconstruction are variable and depend largely on the efficacy of motor re-education of the transferred muscle to perform a new function. The long-term goal of our research is to determine whether iTBS combined with physical rehabilitation can improve motor re-education after reconstruction. As a first step, the purpose of this proposal is to determine the effect of iTBS on corticomotor excitability of proximal muscles in nonimpaired individuals and two groups of individuals with tetraplegia: individuals with and without upper limb reconstruction.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for all subjects with tetraplegia:

  • Injury to the lower cervical spinal cord at least one year prior to the date of participation
  • Motor function classified according to the American Spinal Injury Association International Standards for Neurological Classification of Spinal Cord Injury at levels ranging from C5-C8

Inclusion criteria

for the subjects with tetraplegia and upper limb reconstruction:

  • At least one year post-operative from tendon or nerve transfer surgery of the upper limb

Exclusion criteria

for all subjects with tetraplegia:

  • Presence of concurrent severe medical illness, including unhealed decubiti, use of baclofen pumps, existing infection, cardiovascular disease, significant osteoporosis, or a history of pulmonary complications.
  • Metal implant near head or neck
  • Risk of seizure of history of seizures

Treatment and study plan

intermittent theta burst stimulation

Other

Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.

Primary outcomes

  1. Change in corticomotor excitability

    Time frame: Each subject will participate in five sessions, each session separated by 3 days. After each session, changes in corticomotor excitability will be measured. Changes in excitability will be reported through study completion, an average of one month.

    Corticomotor excitability will be measured via motor evoked potential amplitudes in response to transcranial magnetic stimulation

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Medical University of South Carolina

Registry information

Official study title

Intermittent Theta Burst Stimulation to Promote Motor Re-education After Upper Limb Reconstruction in Tetraplegia

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2017
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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