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Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia

Primary Purpose

Quadriplegia/Tetraplegia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent theta burst stimulation
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Quadriplegia/Tetraplegia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Virginia Commonwealth University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Neurologically Normal

Quadriplegia

Quadriplegia with upper limb reconstruction

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
August 24, 2017
Last Updated
November 13, 2020
Sponsor
Virginia Commonwealth University
Collaborators
Medical University of South Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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1. Study Identification

Unique Protocol Identification Number
NCT03277521
Brief Title
Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia
Official Title
Intermittent Theta Burst Stimulation to Promote Motor Re-education After Upper Limb Reconstruction in Tetraplegia
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
April 16, 2018 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
Medical University of South Carolina, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quadriplegia/Tetraplegia

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurologically Normal
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quadriplegia
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Quadriplegia with upper limb reconstruction
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intermittent theta burst stimulation
Intervention Description
Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.
Primary Outcome Measure Information:
Title
Change in corticomotor excitability
Description
Corticomotor excitability will be measured via motor evoked potential amplitudes in response to transcranial magnetic stimulation
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carrie L Peterson, PhD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35843943
Citation
Mittal N, Majdic BC, Peterson CL. Intermittent theta burst stimulation modulates biceps brachii corticomotor excitability in individuals with tetraplegia. J Neuroeng Rehabil. 2022 Jul 17;19(1):73. doi: 10.1186/s12984-022-01049-9.
Results Reference
derived

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Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia

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