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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
The first part of the study utilizes a crossover design, while the second part utilizes a parallel design.
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
iTBS and PCMS 		iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
  • 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 in 190 seconds).
  • 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.
  • Behavioral: Exercise
    The motor training will be focused on participant's hand motor function such as grasping function.
Sham Comparator
Sham iTBS and PCMS 		Sham iTBS and PCMS will be administered and functional and physiological outcomes will be measured before and after the intervention.
  • 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.
Active Comparator
iTBS and PCMS with exercise 		Participants will complete iTBS and PCMS with exercise for 10 sessions.
  • 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 in 190 seconds).
  • 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.
  • Behavioral: Exercise
    The motor training will be focused on participant's hand motor function such as grasping function.
Sham Comparator
Sham iTBS and sham PCMS with exercise 		Participants will complete sham stimulation with exercise for 10 sessions.
  • Other: Sham iTBS
    Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.
  • 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.

Recruiting Locations

The State University of New York at Buffalo
Buffalo, New York 14214
Contact:
Karen Barnes
716-829-6718
barneska@buffalo.edu

More Details

Status
Recruiting
Sponsor
State University of New York at Buffalo

Study Contact

Hang Jin Jo, PhD
716-829-2905
hangjinj@buffalo.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.