Corticospinal Excitability After rTMS in Spinal Cord Injury Patients
1 other identifier
interventional
12
1 country
1
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Dec 2016
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 2, 2016
CompletedStudy Start
First participant enrolled
December 1, 2016
CompletedFirst Posted
Study publicly available on registry
January 9, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJune 30, 2021
June 1, 2021
3 months
October 2, 2016
June 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Spasticity
Assessment by modified ashworth scale
three weeks (during stimulation protocol)
Spinal excitability
Spinal excitability measures will be assessed by electrical stimulation of the tibial nerve (H-reflex and homosynaptic depression). The volunteer should stay in prone position for the stimulation of the tibial nerve (in the region of the popliteal fossa). The spinal cord excitability will be assessed by Hoffman reflex (Hr) and homosynaptic depression (DH) before intervention and immediately, 30 and 60 minutes after. The ration of maximal Hr/ maximal M-wave amplitude and interestimulus interval of 150ms, 200ms, 250 ms and 300ms of the Hr recovery curve were observed when assessing outcome data.
three weeks (during stimulation protocol)
Secondary Outcomes (1)
Cortical excitability
three weeks (during stimulation protocol)
Study Arms (3)
High frequency rTMS
EXPERIMENTALVolunteers will be submitted to high frequency of repetitive transcranial magnetic stimulation (10Hz)
Low frequency rTMS
EXPERIMENTALVolunteers will be submitted to low frequency of repetitive transcranial magnetic stimulation (1Hz)
Sham rTMS
SHAM COMPARATORVolunteers will be submitted to sham session of repetitive transcranial magnetic stimulation
Interventions
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.
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
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.
Eligibility Criteria
You may qualify if:
- Right-handed (assessed by Edinburgh Handedness Inventory)
- Incomplete Spinal cord injury thoracic or lombar levels
- Sensorio-motor impairment C or D according to American Spinal Cord Injury Association (ASIA)
- To be on chronic stage of injury (\> 8 months);
- Strength grade of hip flexors and knee extensors ≥ 1 according to Medical Research Council;
- Not to be a community walker
You may not qualify if:
- Pregnancy
- Presence of metallic implant close to the target stimulation area
- Acute eczema under the target stimulation area
- Pacemaker
- History of seizures or epilepsy
- Hemodynamic instability
- History of neurological or orthopedic disease not related to spinal cord injury
- Cognitive impairment
- knee, ankle or hip flexor contracture superior to 20º;
- Changes on medication during the study execution
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Federal University of Pernambuco, Applied Neuroscience Laboratory
Recife, Pernambuco, 50670-901, Brazil
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kátia M Silva, PhD
Universidade Federal de Pernambuco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
October 2, 2016
First Posted
January 9, 2017
Study Start
December 1, 2016
Primary Completion
March 1, 2017
Study Completion
June 1, 2017
Last Updated
June 30, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share