Cortico-Spinal Intermittent Theta Burst Stimulation Propelling Sensorimotor Function Recovery in Complete Spinal Cord Injury: Randomized Control Trial Protocol

Abstract

Background: Intermittent theta burst stimulation (iTBS) is a non-invasive stimulation technique to induce neuronal and synaptic plasticity. The induced cortical plasticity is imperative in the recovery of motor and sensory functions. Spinal cord injury (SCI) causes damage to neurons and results in sensorimotor dysfunction. The effect of iTBS on recovery of motor and sensory dysfunction in complete SCI (cSCI) is still elusive. AIM: This study aims to assess the effect of iTBS on cortico-spinal tract integrity, plasticity, and regaining of motor and sensory function in cSCI patients. The rationale behind using an iTBS protocol is to modify and augment the communication between spared neurons of the cortico-spinal tract and strengthen the synaptic transmission, which will improve motor function in underlying muscles. Method: A total of 48 patients will be recruited and randomly divided into placebo and real stimulation groups. iTBS along with a rehabilitation program will be administered to the placebo and real stimulation groups. Follow-up will be done at 1 month, 2 months, and 3 months after the intervention. Result: The outcome of the study will be defined by electrophysiological parameters elicited by single and paired-pulse stimulation, ASIA score, pain, activities of daily life, quality of life, anxiety, depression, and biomarkers related to SCI. The results of this study will uncover the effectiveness of iTBS stimulation on (i) recovery of motor and sensory function in cSCI (ii) excitability of cortico-spinal tract (iii) neurological recovery and modulation of pain (iv) cortical reorganization after injury. Conclusion: Intermittent theta-burst stimulation (iTBS) in conjunction with individualised rehabilitation programme may serve as an integrated strategy to rejuvenate locomotor abilities and improve overall quality of life for people with complete spinal cord injuries (SCI). Keywords: Spinal Cord Injury, Intermittent Theta Burst Stimulation, Excitatory-inhibitory circuitry, synaptic plasticity, Physical Rehabilitation, American Spinal Injury Association Impairment Scale.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This work was funded by the Department of Biotechnology (DBT) Ministry of Science and Technology, Government of India in 2019 (BT_2052).

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval has been obtained from the Institutional Ethical Committee of All India Institute of Medical Sciences, Delhi (Project Ref. Id: IECPG/551/7/2022). The study is registered in Clinical Trials Registry- India (CTRI) with reference number CTRI/2022/11/047038.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.Though this is an protocol so doesn't contain any data.

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