Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia

Not Applicable

Completed

• Conditions: Quadriplegia/Tetraplegia
• Interventions: Other: Intermittent theta burst stimulation

• Registration Number: NCT03277521
• Lead Sponsor: Virginia Commonwealth University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-08-24
• Study First Submitted QC: 2017-09-05
• Study First Posted: 2017-09-11
• Study Start: 2018-04-16
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neurologically Normal	Intermittent theta burst stimulation	Neurologically normal subjects (i.e., nonimpaired) will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
Quadriplegia with upper limb reconstruction	Intermittent theta burst stimulation	Individuals with quadriplegia and upper limb reconstruction will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.
Quadriplegia	Intermittent theta burst stimulation	Individuals with quadriplegia will be recruited for participation in three sessions of intermittent theta burst stimulation (iTBS), each consisting of sham iTBS applied to the hotspot of the target muscle and active iTBS; sham iTBS always be will administered first to minimize the potential for carry over effects. Sessions will be separated by at least 3 days to minimize the potential for carry over effects. Before and 10, 20 and 30 minutes after each iTBS session, motor evoked potentials (MEPs) will be recorded in order to quantify changes in corticomotor excitability.

Primary Outcome Measures

Name	Time	Method
Change in corticomotor excitability	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

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond, Virginia, United States