Ignite Creation Date:
2024-05-06 @ 9:35 AM
Last Modification Date:
2024-10-26 @ 12:16 PM
Study NCT ID:
NCT03014999
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2016-10-02
Brief Title:
Corticospinal Excitability After rTMS in Spinal Cord Injury Patients
Sponsor:
Universidade Federal de Pernambuco
Organization:
Universidade Federal de Pernambuco
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
After given prior informed consent volunteers will be submitted to three randomized and counterbalanced sessions using a website randomizationcom by a non-involved researcher At study beginning volunteers will be evaluated through structured questionnaire and each session will comprise the following experimental sequence
1 Quantity and quality of sleep It will be enquired how many hours the volunteer slept in the last night The quality of the sleep will be measured through an analogue scale graded from 0 worst quality of sleep to 10 points best quality of sleep
2 Type of eating All the individuals will be asked about ingestion of food and drinks that could change the cortical excitability e g coffee chocolate energetic soda e etcc If positive researchers will record the time since of ingestion and quantify the amount of food
3 Fatigue and motivation level It will be measured through an analogue scale graded from 0 lower fatigue or motivation levels to 10 points greater fatigue or motivation levels
4 Spasticity It will be assessed by the modified Ashworth scale ranging from 0 to 4 Performs the passive drive member to be measured and observing the time it arises the resistance difficult the passive movement This scale will be tested bilaterally in the muscles of the lower limbs the tested muscles are the quadriceps adductors hamstring dorsiflexors hip flexors and flexors plant The scale always applies by the same evaluator
5 Spinal cord activity the level of excitability of spinal cord will be measured through the following outcomes
Hoffman reflex H reflex the H reflex will be elicited by a percutaneous electrical stimulation on tibial nerve delivered on popliteal fossa and recorded the electromyographic responses from the soleus muscle The values of maximal H reflex M wave and maximal H reflex and maximal M wave ratio HM ratio will be obtained through a recruitment curve
The recruitment curve will start with a stimulus intensity delivered from 2 milliampere mA and increasing on steps of 1 mA until to M wave curve stabilization no increasing of the M wave amplitude
Homosynaptic depression HD the HD will be obtained through a serie of two consecutive stimuli separated by a interstimulus interval from 30 ms until 10000 ms The stimuli will be delivered on popliteal fossa and the electromyographic responses from soleus muscle will be recorded The stimuli will be delivered with the intensity necessary to produce the maximal H reflex this information will be available in the recruitment curve as stated before The difference between the first and the second stimuli for each interstimulus interval will give rise to the recovery curve
6 Cortical excitability the cortical excitability will be measured through the motor evoked potential MEP through simple pulse transcranial magnetic stimulation BiStim2 Magstim UK 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 held manually at 45 degrees from the midline will be placed over the right primary motor cortex C3 - 1020 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 MEP value will be obtained through twenty suprathreshold 130 of RMT stimuli that will be delivered on primary motor cortex C3
7 rTMS 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 at 45 degrees from the midline will be placed over the right primary motor cortex C3 - 1020 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 - 1020 System and based on previous studies will be performed rTMS protocols Low frequency protocol 1 hertz Hz 90 RMT 1500 stimuli 1 train High frequency protocol 10 Hz 90 RMT 45 trains 40 stimuli per train inter interval of 28 seconds 1800 stimuli Sham rTMS will be performed with low frequency 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 left primary motor area After each rTMS session presence of adverse effects will be computed
8 Spasticity this evaluation will be performed immediately after T0 thirty minutes after T1 and 1 hour after T2 the rTMS The procedures will be conducted following the same protocol
9 Spinal cord activity this evaluation will be performed immediately after T0 thirty minutes after T1 and 1 hour after T2 the rTMS The procedures will be conducted following the same protocol
10 Cortical brain activity this evaluation will be performed after each revaluation of spinal cord activity T0 T1 and T2 The procedures will be conducted following the same protocol
1 Quantity and quality of sleep It will be enquired how many hours the volunteer slept in the last night The quality of the sleep will be measured through an analogue scale graded from 0 worst quality of sleep to 10 points best quality of sleep
2 Type of eating All the individuals will be asked about ingestion of food and drinks that could change the cortical excitability e g coffee chocolate energetic soda e etcc If positive researchers will record the time since of ingestion and quantify the amount of food
3 Fatigue and motivation level It will be measured through an analogue scale graded from 0 lower fatigue or motivation levels to 10 points greater fatigue or motivation levels
4 Spasticity It will be assessed by the modified Ashworth scale ranging from 0 to 4 Performs the passive drive member to be measured and observing the time it arises the resistance difficult the passive movement This scale will be tested bilaterally in the muscles of the lower limbs the tested muscles are the quadriceps adductors hamstring dorsiflexors hip flexors and flexors plant The scale always applies by the same evaluator
5 Spinal cord activity the level of excitability of spinal cord will be measured through the following outcomes
Hoffman reflex H reflex the H reflex will be elicited by a percutaneous electrical stimulation on tibial nerve delivered on popliteal fossa and recorded the electromyographic responses from the soleus muscle The values of maximal H reflex M wave and maximal H reflex and maximal M wave ratio HM ratio will be obtained through a recruitment curve
The recruitment curve will start with a stimulus intensity delivered from 2 milliampere mA and increasing on steps of 1 mA until to M wave curve stabilization no increasing of the M wave amplitude
Homosynaptic depression HD the HD will be obtained through a serie of two consecutive stimuli separated by a interstimulus interval from 30 ms until 10000 ms The stimuli will be delivered on popliteal fossa and the electromyographic responses from soleus muscle will be recorded The stimuli will be delivered with the intensity necessary to produce the maximal H reflex this information will be available in the recruitment curve as stated before The difference between the first and the second stimuli for each interstimulus interval will give rise to the recovery curve
6 Cortical excitability the cortical excitability will be measured through the motor evoked potential MEP through simple pulse transcranial magnetic stimulation BiStim2 Magstim UK 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 held manually at 45 degrees from the midline will be placed over the right primary motor cortex C3 - 1020 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 MEP value will be obtained through twenty suprathreshold 130 of RMT stimuli that will be delivered on primary motor cortex C3
7 rTMS 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 at 45 degrees from the midline will be placed over the right primary motor cortex C3 - 1020 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 - 1020 System and based on previous studies will be performed rTMS protocols Low frequency protocol 1 hertz Hz 90 RMT 1500 stimuli 1 train High frequency protocol 10 Hz 90 RMT 45 trains 40 stimuli per train inter interval of 28 seconds 1800 stimuli Sham rTMS will be performed with low frequency 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 left primary motor area After each rTMS session presence of adverse effects will be computed
8 Spasticity this evaluation will be performed immediately after T0 thirty minutes after T1 and 1 hour after T2 the rTMS The procedures will be conducted following the same protocol
9 Spinal cord activity this evaluation will be performed immediately after T0 thirty minutes after T1 and 1 hour after T2 the rTMS The procedures will be conducted following the same protocol
10 Cortical brain activity this evaluation will be performed after each revaluation of spinal cord activity T0 T1 and T2 The procedures will be conducted following the same protocol
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None