Health TrialsbyHealthPanel

Neuromodulation to Improve Grasping Function After SCI

ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorState University of New York at Buffalo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • iTBS

    Other intervention

    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).

  • Sham iTBS

    Other intervention

    Sham iTBS protocols will be applied with the same parameters as in iTBS protocol. However, sham coil will be used.

  • PCMS

    Other intervention

    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.

  • Sham PCMS

    Other intervention

    During PCMS, the same parameters will be used as in real PCMS but sham TMS coil will be used with minimum PNS intensity.

  • Exercise

    Behavioral

    The motor training will be focused on participant's hand motor function such as grasping function.

Treatment groups

54 Participants
are divided into 4 treatment groups
Group A: iTBS and PCMSActive comparator 2 interventions
Group B: Sham iTBS and PCMSSham comparator 2 interventions
Group C: iTBS and PCMS with exerciseActive comparator 3 interventions
Group D: Sham iTBS and sham PCMS with exerciseSham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Motor evoked potential (MEP)

Transcranial magnetic stimuli (TMS) will be delivered through a figure-of-eight coil over primary motor cortex to the optimal scalp position for activation of hand muscles. The optimal scalp position will be determined by moving the coil in small steps along the hand representations of the primary motor cortex to find the region where the largest MEP can be evoked with the minimum intensity in the targeted muscle. Twenty MEPs will be collected and the peak-to-peak amplitude of MEP will be averaged across trials.

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 outcomes

1

Maximum voluntary contraction (MVC)

Individuals will perform a MVC of the targeted hand muscle (first dorsal interosseous) through surface EMG electrodes. The investigators will collect two MVC trials and use the average of the two.

Time frame
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
2

Grip force

Grip force will be assessed with hand grip dynamometer. The highest value of the three trials will be used.

Time frame
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.
3

Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT)

TRI-HFT is clinical assessment tool to measure specifically unilateral pinch and grasp hand function.

Time frame
For the first study, the time frame will be one day. For the second study, the time frame will be 4 weeks.

Other outcomes

Sponsors and contacts

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

State University of New York at Buffalo

Lead sponsor

Source ClinicalTrials.gov
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