Multisite Transspinal Stimulation for Spinal Cord Injury Recovery
This study is testing a new way to help people with spinal cord injuries (SCI) recover. It uses a treatment called multisite transspinal stimulation, which involves placing electrodes on your neck and lower back to send electrical signals to your spinal cord. This stimulation will be given either while you are resting or during robotic gait training (training to walk with a robot's help). The goal is to see if this treatment can help reconnect nerve pathways and improve standing and walking ability. We are looking for 36 participants, aged 18 to 70, with incomplete spinal cord injuries (AIS B, C, D). Success will be measured by changes in your leg muscle reflexes (Soleus H-reflex) before and after the treatment sessions.
- Study design
- This is an interventional pilot study with a planned enrollment of 36 participants. It is testing the safety and effectiveness of a new treatment.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your leg muscle reflexes will be measured before and one day after all intervention sessions are completed.
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Multisite Transspinal Stimulation for Augmenting Recovery in Spinal Cord Injury
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- MARIA KNIKOU, PT, MBA, PhD · PRINCIPAL_INVESTIGATOR · City University of New York, College of Staten Island
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Soleus H-reflex recruitment curveBefore and 1 day after all intervention sessions are completed.
Investigators will deliver single pulses of 1 ms duration every 5 seconds at increasing intensities to the posterior tibial nerve behind the knee to assemble the soleus H-reflex recruitment curve. At least 50 responses will be recorded. From the recruitment curve, the investigators will estimate changes in the slope and stimulation intensities for reflex threshold.
- Soleus H-reflex rate-dependent depressionBefore and 1 day after all intervention sessions are completed.
Soleus H-reflexes following posterior tibial nerve of the right leg behind the knee with a 1-ms pulse randomly at 1, 3, 5, 8, and 10 s inter-pulse intervals will be recorded. At each inter-pulse interval, 15 responses will be recorded. Stimulation will be delivered via a ball shape electrode and responses will be recorded from leg muscles with surface electrodes. The smaller the soleus H-reflex amplitude when evoked every 1 second the larger the spinal inhibition. Recovery of spinal inhibition will be considered when the soleus H-reflex depression at 1 second is statistically significant different before and after the intervention.
- Soleus H-reflex phase-dependent modulation during steppingBefore and 1 day after all intervention sessions are completed.
Each participant will step with the assistance of the Lokomat, and the investigators will record soleus H-reflexes randomly across 16 equal time bins into which each step cycle is divided. The posterior tibial nerve behind the knee will be stimulated at motor threshold. Stimulations will be triggered based on the foot switch signal. Under physiological conditions, the soleus H-reflex during walking largely is facilitated during the stance phase and inhibited during the swing phase. Recovery of spinal locomotor circuits will be based on the amplitude of the soleus H-reflex during the stance and swing phases of gait, and how much is facilitated and inhibited during the stance and swing phases after intervention compared to before intervention for each participant.
- Leg transspinal evoked potentials recruitment curvesBefore and 1 day after all intervention sessions are completed.
The investigators will deliver single 1 ms pulses every 5 seconds at increasing intensities with a surface electrode to the low back to assemble the recruitment curves of transspinal evoked potentials recorded from leg muscles with surface electrodes. Participants will lay on their back on a treatment table. From the recruitment curve, the slope and excitation threshold will be established and the intervention will be considered effective when statistical significant differences on their amplitude between before and after values is established.
- Flexor carpus radialis H-reflex recruitment curveBefore and 2 days after all intervention sessions are completed.
The investigators will stimulate the median nerve with a bipolar surface electrode at the elbow with single 1-ms pulses at increasing intensities every 5 seconds while participants are seated. At least 50 responses will be recorded. From the recruitment curve, the slope and excitation threshold will be established. The intervention will be considered effective when statistical significant differences between before and after values is found.
- Flexor carpus radialis H-reflex rate dependent depressionBefore and 2 days after all intervention sessions are completed.
Flexor carpus radialis H-reflexes following median nerve stimulation with a surface bipolar electrode of the right arm at the elbow with a 1-ms pulse will be recorded randomly at 1, 3, 5, 8, and 10 s inter-pulse intervals. At each inter-pulse interval, 15 responses will be recorded. Responses will be recorded from arm muscles with surface electrodes. Under physiological conditions, the reflex is smaller when evoked every 1 second compared to that evoked every 10 seconds. Recovery of spinal inhibition will be considered when a smaller reflex is evoked every 1 second after the intervention compared to that observed before intervention.
- Arm transspinal evoked potentials recruitment curvesBefore and 2 days after all intervention sessions are completed.
The investigators will deliver single 1 ms pulses every 5 seconds at increasing intensities to the back of the neck with a surface electrode to assemble the recruitment curves of transspinal evoked potentials recorded from arm muscles with surface electrodes. Participants will lay on their back on a treatment table. From the recruitment curve, the slope and excitation threshold will be established and the intervention will be considered effective when statistical significant differences between before and after intervention is established.