TsDCS and Physical Therapy After Incomplete Spinal Cord Injury

NCT06886386 | Enrolling By Invitation DMC

• 1 other identifier: tsDCS_physical therapy_iSCI
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

trans-spinal direct current stimulation; physical therapy; spinal cord injury; motor function

Outcome Measures

Primary Outcomes (1)

• Changes in the Upper and Lower Extremities Motor Scale (UEMS and LEMS) from ASIA.

  It is an international scale. The UEMS and LEMS are composed of the sum of muscle function grading for the five key muscles of the upper and lower limbs (respectively) as defined by ASIA. The score for each muscle is graded from '0' to '5', and the total score can range from '0' to '50'. To calculate this, the scores for the five muscles of each limb (upper and lower/ left and right) should be summed. The higher the score, the better the motor function.

  Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.

Secondary Outcomes (4)

• Changes on American Spinal Cord Injury Association - Impairment Scale (AIS)

  Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.

• Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)

  Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.

• Change from Modified Ashworth scale (MAS)

  Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.

• Changes on Patient Global Impression of Change Scale - (PGICS)

  After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.

Study Arms (2)

active tsDCS + physical therapy

EXPERIMENTAL

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.

Device: Trans-spinal direct current stimulation

sham tsDCS + physical therapy

SHAM COMPARATOR

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.

Device: Trans-spinal direct current stimulation

Interventions

Trans-spinal direct current stimulation 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.

Also known as: Physical therapy

active tsDCS + physical therapy; sham tsDCS + physical therapy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50670-900, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Physical Therapy

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: March 20, 2025
• Study Start: March 3, 2025
• Primary Completion: November 10, 2025
• Study Completion: November 10, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

BR (1)