Corticospinal Excitability After rTMS in Spinal Cord Injury Patients

NCT03014999 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2021-06-30

No results posted yet for this study

Summary

A crossover trial with spinal cord injury volunteers will be conducted. Three sessions will be performed once a week in a counterbalanced order and at least with seven days washout period to minimize carry-over effects. In each session, volunteers will be submitted to quantity and quality of sleep, type of eating, fatigue and motivation level, Ashworth scale spasticity, cortical brain activity measures through simple pulse transcranial magnetic stimulation (pTMS), spinal cord activity measures through electrical stimulation and non-invasive brain stimulation (rTMS)

Conditions

  • Spinal Cord Injury

Interventions

DEVICE

High frequency rTMS (repetitive Transcranial Magnetic Stimulation)

Higher cortical representation area of first right dorsal interosseous muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and at 45 degrees from the midline over the right primary motor cortex (C3 - 10/20 System). Then, will be determined the rest motor threshold by finding the lowest stimulator output that elicit motor evoked potential at least 50μV. After determined the RMT, the coil will be positioned over the scalp (Cz - 10/20 System). Thereafter, RMT will be measure. rTMS protocols was based on previous studies. High frequency protocol: 10Hz, 90% RMT, 45 trains, 40 stimuli per train, inter interval of 28s, 1800 stimuli. After each rTMS session, presence of adverse effects will be computed.

DEVICE

Low frequency rTMS (repetitive Transcranial Magnetic Stimulation)

Initially, the higher cortical representation area (hotspot) of first right dorsal interosseous (FDI) muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and at 45 degrees from the midline, will be placed over the right primary motor cortex (C3 - 10/20 System). Then, will be determined the rest motor threshold (RMT) by finding the lowest stimulator output that elicit motor evoked potential (MEP) at least 50 microvolts (μV). After determined the RMT, the coil will be positioned over the scalp (Cz - 10/20 System). Thereafter, RMT will be measure. Low frequency protocol: 1Hz, 90% RMT, 1500 stimuli (1 train). After each rTMS session, presence of adverse effects will be computed

DEVICE

sham rTMS (repetitive Transcranial Magnetic Stimulation)

The hotspot of first right dorsal interosseous (FDI) muscle will be determinate through a figure-eight coil connected to the magnetic stimulator positioned over the motor primary cortex (C3). Then, the motor threshold (RMT) of FDI will be measure. Sham rTMS will be performed with low frequency (1Hz, 90% RMT, 1500 stimuli) protocol using two coils. The first one - connected to the stimulator - will be positioned on a coil support close to the volunteer but not visible. Therefore, characteristic stimulation noises will be audible. The second - disconnected to the stimulator - will be placed over primary motor area Cz. After each rTMS session, presence of adverse effects will be computed.

Sponsors & Collaborators

  • Universidade Federal de Pernambuco

    lead OTHER

Principal Investigators

  • Kátia M Silva, PhD · Universidade Federal de Pernambuco

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2017-03-31
Completion
2017-06-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03014999 on ClinicalTrials.gov