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Theta Burst Stimulation to Promote Motor Re-education in Tetraplegia

NCT ID: NCT03277521

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-16

Study Completion Date

2020-02-28

Brief Summary

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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

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Conditions

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Quadriplegia/Tetraplegia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Neurologically Normal

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.

Group Type ACTIVE_COMPARATOR

Intermittent theta burst stimulation

Intervention Type OTHER

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

Quadriplegia

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.

Group Type ACTIVE_COMPARATOR

Intermittent theta burst stimulation

Intervention Type OTHER

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

Quadriplegia with upper limb reconstruction

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.

Group Type ACTIVE_COMPARATOR

Intermittent theta burst stimulation

Intervention Type OTHER

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

Interventions

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Intermittent theta burst stimulation

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carrie L Peterson, PhD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 35843943 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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FP00005482

Identifier Type: OTHER

Identifier Source: secondary_id

P2CHD086844

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HM20010643

Identifier Type: -

Identifier Source: org_study_id