Neuromodulation After Spinal Cord Injury to Improve Limb Function
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: rTMS, Sham rTMS, Motor training.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury, Spinal Cord Injury Cervical. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
The main goal of rehabilitation strategies in humans with spinal cord injury (SCI) is to strengthen transmission in spared neural networks to restore functional movements. Recent evidence showed that neuromodulation approaches may increase the transmission in corticospinal pathway in humans with SCI and improve functional outcomes. Therefore, the investigators aim to investigate how the noninvasive brain stimulation protocols affects neuroplasticity of corticospinal pathway. Specifically, the investigators will use the repetitive transcranial magnetic stimulation (rTMS) to explore its effect. The investigators will investigate the effect of short-term and long-term rTMS application in individuals with SCI.
Interventions
- Other rTMS
Intermittent 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 i - Other Sham rTMS
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used. - Behavioral Motor training
The motor training will be focused on participant's hand motor function such as grasping function.
Primary outcome measures
- Motor evoked potentials (MEP) [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 outcome measures (2)
- Maximum voluntary contraction (MVC) [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.]
- Power Grip Forces [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.]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
For both healthy individuals and those with SCI:
- 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
- History of seizures
- Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs
- Pregnant females
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Kimball Tower at The State University of New York at Buffalo — Buffalo
Identifiers
NCT: NCT06815601 · 00007259