TsDCS and Physical Therapy After Incomplete Spinal Cord Injury

NCT ID: NCT06886386

Last Updated: 2025-03-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-03
• Study Completion Date: 2025-11-10

Brief Summary

The aim of this study is to evaluate the effects of tsDCS combined with physical therapy on the recovery of motor function in adult patients with chronic incomplete spinal cord injury.

Detailed Description

A randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions). Active or sham tsDCS will be combined with physical therapy to verify the improvement of motor function in patients with incomplete spinal cord injury. Assessments will be performed before and after therapeutic sessions and at the 30-day follow-up after the intervention, through: (i) ASIA Lower and Upper Extremities Motor Scale (LEMS and UEMS), (ii) ASIA Impairment Scale (AIS), (iii) Ashworth Modified Scale; (iv) the Functional Independence Measure (SCIM-III), and (v) the Patient Global Impression of Change Scale - (PGICS).

Conditions

Spinal Cord Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

active tsDCS + physical therapy

a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between physical therapy combinated and active tsDCS in improving the motor function of adult patients with chronic incomplete spinal cord injury. The sessions will be performed five times a week for a month.

Group Type: EXPERIMENTAL

Trans-spinal direct current stimulation

Intervention Type: DEVICE

Patients with a neurological level above T10 will receive cervical tsDCS (anode electrode at C7, and the cathode electrode on the right shoulder). Patients with a neurological level from T10 onwards will receive thoracic tsDCS (anode electrode at T10, and the cathode electrode at the iliac crest). (i) Experimental group (active tsDCS): electrical stimulator (Neuroconn/Germany) connected to a pair of saline-soaked sponge electrodes (35 cm²) with a current intensity of 2.5 mA for 20 minutes. (ii) Control group (sham tsDCS) with electrodes positioned at the same locations as active tsDCS, for 30 seconds (the setup will remain for the full 20 minutes). Thus, patients will experience the initial sensations at the stimulated site, without inducing an effect. Physical therapy will be performed during tsDCS (45 minutes), based on scientific evidence, considering patient preferences, and respecting motor learning theory and neuroplasticity principles, focusing on motor function recovery.

sham tsDCS + physical therapy

a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between physical therapy combinated and sham tsDCS in improving the motor function of adult patients with chronic incomplete spinal cord injury. The sessions will be performed five times a week for a month.

Group Type: SHAM_COMPARATOR

Trans-spinal direct current stimulation

Intervention Type: DEVICE

Patients with a neurological level above T10 will receive cervical tsDCS (anode electrode at C7, and the cathode electrode on the right shoulder). Patients with a neurological level from T10 onwards will receive thoracic tsDCS (anode electrode at T10, and the cathode electrode at the iliac crest). (i) Experimental group (active tsDCS): electrical stimulator (Neuroconn/Germany) connected to a pair of saline-soaked sponge electrodes (35 cm²) with a current intensity of 2.5 mA for 20 minutes. (ii) Control group (sham tsDCS) with electrodes positioned at the same locations as active tsDCS, for 30 seconds (the setup will remain for the full 20 minutes). Thus, patients will experience the initial sensations at the stimulated site, without inducing an effect. Physical therapy will be performed during tsDCS (45 minutes), based on scientific evidence, considering patient preferences, and respecting motor learning theory and neuroplasticity principles, focusing on motor function recovery.

Interventions

Trans-spinal direct current stimulation

Patients with a neurological level above T10 will receive cervical tsDCS (anode electrode at C7, and the cathode electrode on the right shoulder). Patients with a neurological level from T10 onwards will receive thoracic tsDCS (anode electrode at T10, and the cathode electrode at the iliac crest). (i) Experimental group (active tsDCS): electrical stimulator (Neuroconn/Germany) connected to a pair of saline-soaked sponge electrodes (35 cm²) with a current intensity of 2.5 mA for 20 minutes. (ii) Control group (sham tsDCS) with electrodes positioned at the same locations as active tsDCS, for 30 seconds (the setup will remain for the full 20 minutes). Thus, patients will experience the initial sensations at the stimulated site, without inducing an effect. Physical therapy will be performed during tsDCS (45 minutes), based on scientific evidence, considering patient preferences, and respecting motor learning theory and neuroplasticity principles, focusing on motor function recovery.

Intervention Type: DEVICE

Other Intervention Names

Physical therapy

Eligibility Criteria

Inclusion Criteria

• Clinical diagnosis of incomplete spinal cord injury by a neurologist
• Diagnosis time greater than 12 months

Exclusion Criteria

• Patients with additional current neurological diagnoses
• Presence of contraindications for tsDCS

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidade Federal de Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Fernanda Natacha Rufino Nogueira

Master in Physical Therapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Applied Neuroscience Laboratory

Recife, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

tsDCS_physical therapy_iSCI

Identifier Type: -

Identifier Source: org_study_id