Health TrialsbyHealthPanel

Paired Stimulation Plasticity for Motor Recovery in Humans With and Without Spinal Cord Injury

ConditionsHealthy ControlSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age19-85
SponsorShirley Ryan AbilityLab

About this trial

This study will investigate how aging and spinal cord injury (SCI) affect the transmission and plasticity of the corticospinal and reticulospinal tracts, which are important pathways for motor control. The study includes two experiments. Experiment 1 will assess corticospinal and reticulospinal tract transmission to lower-limb muscles in older adults with and without SCI. Experiment 2 will examine how aging and spinal cord injury affect the body's ability to strengthen nerve pathways involved in movement. The investigators will compare two pathways that help control leg movement, the corticospinal and reticulospinal pathways, to determine whether aging affects these pathways differently and whether spinal cord injury has a greater effect on the corticospinal pathway.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Male and females between 19-85 years;

Chronic SCI (≥ 1 years post-injury);

T10 or above - American Spinal Injury Association (AIS) Grade C, or D;

Ability to perform a small voluntary ankle dorsiflexion, knee extension, and ankle plantarflexion (as detected by presence of voluntary EMG activity in the rectus femoris, tibialis anterior, and soleus muscles) with at least one leg;

Disqualifiers

Uncontrolled medical problems including pulmonary, cardiovascular, or orthopedic disease;

Any debilitating disease before the SCI that caused exercise intolerance;

Premorbid, ongoing major depression or psychosis, altered cognitive status;

History of head injury or stroke;

Trial population

Vulnerable populations, including children (\<18 years) and pregnant women, will be excluded from this study.

Trial design

Design model

Case-crossover

Time perspective

Cross-sectional

Treatments tested in this trial

  • CST PAS

    Other intervention

    transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brain-to-spinal cord connections

  • RST PAS

    Other intervention

    transcranial magnetic stimulation and peripheral nerve stimulation are given at almost the same time to target brainstem-to-spinal cord connections

  • sham PAS

    Other intervention

    the setup will look and feel the same to the participant as the CST PAS or RST PAS. But one or both of the stimulations is not actually delivered, or it is delivered in a way that does not affect the participant

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: healthy control3 interventions
Group B: spinal cord injury3 interventions

Trial outcomes

Primary outcomes

1

Motor evokoed potential

Transcranial magnetic stimuli (TMS) will be delivered from a Magstim 200 stimulator (Magstim Company) through a double-cone coil with a monophasic current waveform. TMS will be delivered to the optimal scalp position for activation of upper or lower limb muscles. The optimal scalp position will be determined by moving the coil in small steps along the arm/leg muscle representation of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscles. The muscles to be activated will be upper limb muscles such as deltoid, biceps, triceps, extensor carpi radialis, flexor carpi radialis and/or first dorsal interosseous; lower limb muscles such as quadriceps, hamstrings, tibialis anterior, soleus, and/or abductor hallucis muscles. Only the authorized research team will use the device and the investigator will comply with USFDA requirements for monitoring, records and reports. The research team will not market or promote the

Time frame
Periprocedural
2

MVC

Individuals will perform a maximum voluntary contraction (MVC) of the targeted muscles through surface electrodes secured to the skin over the belly of each muscle (Ag-AgCl, 10 mm diameter). The signals will be amplified, filtered (20-1000 Hz), and sampled at 10 kHz for offline analysis.

Time frame
Periprocedural
3

StartReact

The StartReact response will allow us make inferences about the contribution of the reticulospinal tract to spasticity. The StartReact response will be tested using a previously described paradigm in humans with and without SCI. Here, participants will be asked to observe a light-emitting diode (LED) located \~1 m in front of the participants' head. When the LED will illuminate (20 ms), individuals will be asked to perform an isometric elbow, knee and/or ankle flexion or an isometric elbow, knee and/or ankle extension as fast as possible. We will measure the visual reaction time (VRT) as the time from cue to onset of the EMG burst in the elbow muscles after the LED presentation. In some trials, the LED will be presented with either a quiet acoustic stimulus (80 dB, 500 Hz, 50 ms) or a startling acoustic stimulus (SAS, 120 dB, 500 Hz, 50 ms) delivered through a headphone. The time delay between the presentation of the quiet acoustic stimulus and the onset of the EMG response refer as th

Time frame
Periprocedural

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shirley Ryan AbilityLab

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov
Apply now