Neuromodulation to Improve Grasping Function After SCI
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: iTBS, Sham iTBS, PCMS, Sham PCMS.
- Who it may be relevant to
- Registry conditions: Spinal Cord Injury. 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 →
Unsure about the terms? Read our patient guide →
Official title
Neuromodulation to Improve Grasping Function After Spinal Cord Injury
Overview
The goal of this study is to restore the activities of late descending signals with a noninvasive stimulation approach in combination with hand motor training to improve hand function in persons with cervical SCI. The main question it aims to answer is if the inputs to late descending signals above the level of injury and the output of residual late descending signals below the level of injury could be increased. Specifically, in the first part of the study, 30 participants will complete 2 randomized sessions to compare the effect of intermittent theta burst stimulation combined with paired corticospinal motoneuronal stimulation. In the second part of the study, 24 participants will complete either combined stimulation protocol or sham stimulation protocol with exercise training.
Detailed description
The investigators will use paired corticospinal-motoneuronal stimulation (PCMS) in combination with intermittent theta burst stimulation (iTBS). During PCMS, the investigators will use paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation to improve corticospinal transmission and functional recovery in humans with cervical incomplete SCI. In addition, the investigators will investigate how priming iTBS affects neuroplasticity of late corticospinal descending volleys. The investigators will apply iTBS on primary motor cortex prior to paired stimulation with PCMS to facilitate late corticospinal volleys and potentiate the effect of PCMS. In Aim 2, the investigators propose to combine our neuromodulation in Aim 1 with long-term motor training focused on hand grasping to strengthen spared connections and promote functional improvement in humans with cervical incomplete SCI.
Interventions
- Other iTBS
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 iTBS
Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used. - Other PCMS
During PCMS, paired stimulation of the primary motor cortex by transcranial magnetic stimulation to elicit late corticospinal descending volleys and the peripheral nerve by electrical stimulation will be used to improve corticospinal transmission. - Other Sham PCMS
During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity. - Behavioral Exercise
The motor training will be focused on participant's hand motor function such as grasping function.
Primary outcome measures
- Motor evoked potential (MEP) [Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]
Secondary outcome measures (3)
- Maximum voluntary contraction (MVC) [Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]
- Grip force [Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]
- Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT) [Time frame: For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.]
Eligibility criteria
Inclusion criteria
For individuals with SCI:
- Ages 18-75 years
- Chronic SCI (≥1 year of injury)
- Cervical injury at C8 or above
- Individuals who have MEP responses in at least one FDI muscle
Exclusion criteria
- Uncontrolled medical problems including pulmonary or cardiovascular disease
- Premorbid, ongoing major depression or psychosis, altered cognitive status
- History of head injury or stroke
- 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
- Individuals who suffer from a spinal cord disease such as spinal stenosis, spinal bifida or herniated cervical
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The State University of New York at Buffalo — Buffalo
Identifiers
NCT: NCT07433959 · STUDY00009877