Neuromodulation After Spinal Cord Injury to Improve Limb Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorState University of New York at Buffalo
About this trial
The University at Buffalo (UB) Department of Rehabilitation Sciences is looking for adult volunteers with and without spinal cord injuries for a study on hand movement. The goal of the study is to learn about how the brain, nerves, and muscles of the body are connected and perform everyday tasks. This may help us to develop ways to improve the hand functions of people with spinal cord injuries.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Healthy adults between the ages of 18-75 years old who are right-handed
Adults between the ages of 18-75 years old who have had a spinal cord injury (SCI)
Disqualifiers
Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease
Any debilitating disease prior to the SCI that caused exercise intolerance
Ongoing major depression or altered cognitive status
Metal plate in skull
Trial design
Design model
Single group
Treatments tested in this trial
rTMS
Other interventionIntermittent theta burst stimulation (iTBS) will be utilized since they have been reported to have a cortical neuromodulatory effect. The iTBS protocol will be applied over primary motor cortex to investigate its effect on corticospinal excitability and functional outcome. Theta burst stimulation (TBS) consists of bursts of pulses containing 3 pulses at 50 Hz (3 pulses per second) repeated at 200 ms intervals (5 Hz). During iTBS, a 2 second train of TBS is repeated every 10 seconds (600 pulses in 190 seconds).
Sham rTMS
Other interventionSham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
Motor training
BehavioralThe motor training will be focused on participant's hand motor function such as grasping function.
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: rTMSActive comparator 1 intervention
Group B: Sham rTMSSham comparator 1 intervention
Group C: rTMS with motor trainingActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Motor evoked potentials (MEP)
Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.
Time frame
For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.Secondary outcomes
1
Maximum voluntary contraction (MVC)
Individuals will perform a MVC of the targeted hand muscle (first dorsal interosseous) through surface EMG electrodes. The investigators will collect two MVC trials and use the average of the two.
Time frame
For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.2
Power Grip Forces
Power grip force will be measured with hand-held dynamometer.
Time frame
For "rTMS" and "Sham rTMS", the time frame will be one day, before and after each session. For "rTMS with motor training", the time frame will be weekly up to 20 weeks.Sponsors and contacts
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Source ClinicalTrials.gov