TsDCS and Physical Therapy After Incomplete Spinal Cord Injury

Universidade Federal de Pernambuco

Status: Invitation-only

Conditions: Spinal Cord Injury

Treatments: Device: Trans-spinal direct current stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT06886386

tsDCS_physical therapy_iSCI

Details and patient eligibility

About

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.

Full 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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups

active tsDCS + physical therapy

Experimental group

Description:

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.

Treatment:

Device: Trans-spinal direct current stimulation

sham tsDCS + physical therapy

Sham Comparator group

Description:

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.

Treatment:

Device: Trans-spinal direct current stimulation