Effects of Transcranial Magnetic Stimulation in Incomplete Spinal Cord Injury

NCT ID: NCT02899637

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-31
• Study Completion Date: 2017-05-31

Brief Summary

The main objective is to conduct a study protocol to investigate the effects of repetitive Transcranial Magnetic Stimulation (rTMS) on sensory and motor performance of individuals with incomplete spinal cord injury (iSCI) . A double-blind randomized sham-controlled trial of patients with iSCI will be conducted.

Detailed Description

Effective rehabilitation programs for individuals with incomplete spinal cord injury (iSCI) are required either in the acute or in the post-acute care. Rehabilitation techniques based on protocols that selectively stimulate specific pathways along the central nervous system have been considered effective in enhancing neurologic recovery thereby improving functional abilities. The rationale relies on the assumption that the stimulation of the corticospinal tract, primary motor cortex, and spinal cord might induce neuronal reorganization of structures that are largely involved in the control of voluntary movements. In this line of reasoning, protocols involving repetitive transcranial magnetic stimulation (rTMS) have been found effective in enhancing corticospinal synaptic transmission, attenuating neuropathic pain, improving spasticity and sensorimotor function after iSCI. However, controversial findings have also been reported, as other studies showed unaltered central pain, as well as cortical excitability and sensorimotor function. The lack of consistent results is probably associated with differences in stimulation parameters, number of sessions, site of stimulation, chronicity and levels of injury, and outcome measurements of the previous studies. Thus, it is clear that there are remaining gaps in our knowledge and the development of new studies, preferably prospective fully double-blind placebo-controlled trials, is necessary to complement the current knowledge about the effects of rTMS in patients with iSCI.

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Spinal Cord Injury (Active Group)

Active high-frequency Transcranial Magnetic Stimulation

Group Type: EXPERIMENTAL

Active high-frequency Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Spinal Cord Injury (Control group)

Sham high-frequency Transcranial Magnetic Stimulation

Group Type: SHAM_COMPARATOR

Sham high-frequency Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Interventions

Active high-frequency Transcranial Magnetic Stimulation

Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Intervention Type: DEVICE

Sham high-frequency Transcranial Magnetic Stimulation

Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Have a clinical diagnosis of iSCI with nonprogressive etiology
• Clinical stability
• Aged between 18-60 years old
• Score equal to 24 in the Mini-Mental State Examination
• No electroencephalography alterations
• Absence of depression assessed by Hamilton Depression Scale
• Currently receiving inpatient rehabilitation in Physiotherapy Health Center of University of the State of Paraiba, Brazil.

Exclusion Criteria

• Have metal prosthesis in some part of the body
• Use cardiac pacemaker
• Present dementia or neurological disorders which can increase cortical excitability
• Have psychotic or schizophrenic disorders
• Take drugs that reduce seizure threshold or spasticity.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Estadual da Paraiba

OTHER

Sponsor Role: collaborator

University of Sao Paulo

OTHER

Sponsor Role: lead

Responsible Party

Fernando Henrique Magalhães

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fernando H Magalhaes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo

Locations

Universidade Estadual da Paraiba

Campina Grande, Paraíba, Brazil

Countries

Brazil

Central Contacts

Amanda Vitoria L Araujo

Role: CONTACT

amandavitooria@gmail.com

+55 (11) 971212653

References

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Reference Type: DERIVED

PMID: 29110687 (View on PubMed)

Other Identifiers

18753713.0.0000.5187

Identifier Type: -

Identifier Source: org_study_id