NCT05390853

Active tDCS Versus Sham tDCS for Upper Limb Recovery in Incomplete Tetraplegic Patients

Pilot Randomized Controlled Study on Neuromodulation Through Active tDCS Versus Sham tDCS to Support Upper Limb Motor and Functional Recovery in Sub-acute, Incomplete, Tetraplegic Spinal Cord Injured Patients

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Montecatone Rehabilitation Institute S.p.A. · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of the upper limbs, of the hands in particular, represents a priority rehabilitation target. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in addition to the traditional physiotherapy treatment for the functional recovery of the upper limb, in incomplete traumatic tetraplegic subjects in the sub-acute phase after SCI occurrence. Patients hospitalized at the Montecatone Rehabilitation Institute are randomly assigned to Active tDCS or Sham tDCS.

Detailed description

Spinal Cord Injury (SCI) at the cervical level results in motor and sensory impairment below the lesion level and may determine a consistent loss of the use of the upper limbs, with a substantial impact on daily life activities. Therefore, functionality recovery of upper limbs, of the hands in particular, represents a priority rehabilitation target. In cases of incomplete tetraplegia, the main rehabilitation goal is the recovery of the maximum functional capacity, in order to improve autonomy or, in the most serious cases, avoid complications due to immobilization. Studies in the literature show that the most relevant recovery occurs in the first months after SCI and that neuromodulation techniques may facilitate it. Transcranial Direct Current Stimulation (tDCS ) is a non-invasive neuromodulation technique capable of modifying cortical excitability through direct, low intensity current, generated by a programmable medical device and delivered through electrodes placed on the scalp. Some authors have explored its potential role in facilitating functional recovery and treating spasticity in SCI subjects, however there are few studies on the use of neuromodulation induced by tDCS as an aid for the functional recovery of upper limbs in tetraplegic subjects. Moreover, most of such studies are on chronic SCI persons only. The present pilot, randomized controlled study aims at exploring the feasibility and efficacy of an early application of tDCS, in the sub-acute phase after SCI occurrence, for the functional recovery of the upper limb, in addition to the traditional physiotherapy treatment, in incomplete traumatic tetraplegic patients, hospitalized at the Montecatone Rehabilitation Institute. They are randomly assigned to Active tDCS (A) or Sham tDCS (S) (parallel arms design,1:1 allocation ratio). Two tDCS daily sessions for 5 days a week, for 2 consecutive weeks, are carried out simultaneously with the usual rehabilitation treatment of the upper limb, that is administered also at least 4 weeks before and 4 weeks after the tDCS treatment period. Most outcomes are measured up to 4 weeks after the completion of the tDCS treatment period.

Conditions

• Spinal Cord Injury Cervical

Interventions

Type	Name	Description
PROCEDURE	Active tDCS	tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Active stimulation is carried out with a current intensity of 2 milliAmpere. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.
PROCEDURE	Sham tDCS	tDCS application is anodic, in the M1 area (Primary Motor Cortex) right or left, contralateral to the pre-defined target limb. The cathode is positioned in the supraorbital area, contralateral to the anode. Sham stimulation is carried out through a dedicated program, which increases the current for several seconds up to the target intensity and then decreases it gradually in a few seconds, so that subjects experience the same itching and tingling experience as in active stimulation, but they do not receive any significant therapeutic currents. Each tDCS session lasts 20 minutes. tDCS is administered simultaneously during the first 20 minutes of the usual upper limb rehabilitation physiotherapy, which will continue for a further 20 minutes. During the whole study period (10 weeks) each patient is not subjected to any focal treatments in the target upper limb. In the study period, the contralateral limb is rehabilitated and evaluated according to usual practice.

Timeline

• Start date: 2023-05-24
• Primary completion: 2025-10-01
• Completion: 2025-11-01
• First posted: 2022-05-25
• Last updated: 2024-10-22

Locations

1 site across 1 country: Italy