TsDCS and Physical Therapy After Incomplete Spinal Cord Injury
March 14, 2025 updated by: Fernanda Natacha Rufino Nogueira, Universidade Federal de Pernambuco
Effects of Trans-spinal Direct Current Stimulation Combined to Physical Therapy in Patients with Chronic Incomplete Spinal Cord Injury
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.
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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).
Study Type
Interventional
Enrollment (Estimated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pernambuco
-
Recife, Pernambuco, Brazil, 50670-900
- Applied Neuroscience Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
Other Names:
|
|
Sham Comparator: 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.
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in the Upper and Lower Extremities Motor Scale (UEMS and LEMS) from ASIA.
Time Frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes on American Spinal Cord Injury Association - Impairment Scale (AIS)
Time Frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
|
This is international scale, it is the gold standard for the diagnosis of spinal cord injury and is used worldwide. The AIS categorizes the lesion from full spinal cord injury to normal degree (severity of the injury), according to sensory-motor preservation, passing through degrees of spinal cord injury (A , B, C, D or E). (i) AIS A (Complete): no motor or sensory function preserved in the sacral regions (S4-S5); (ii) AIS B (Sensory incomplete): sensory function, but not motor, preserved below the neurological level; (iii) AIS C (Motor incomplete): motor function preserved, with more than half of the muscles scoring less than 3; (vi) AIS D (Motor incomplete): motor function preserved, with more than half of the muscles scoring 3 or more; and (v) AIS E (Normal): normal motor and sensory function. Observations: "AIS A" represents the worse outcome regarding the severity of the injury, and "AIS E" represents the better. |
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)
Time Frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
|
The scale assesses patients' ability to perform tasks inherent to spinal cord injury and detects improvements in their functionality.
The SCIM-III is a scale from 0 to 100 points and divides into three main domains: self-care (feeding, bathing, dressing and cleanliness), breathing, sphincter control and mobility (indoors and out home and transfers).
Higher scores on the SCIM III reflect higher levels of independence.
|
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)
Time Frame: Before the sessions, after 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
|
The Modified Ashworth Scale is a clinical measure for assessing muscle tone during passive movement with speed dependence and shows good validity and reproducibility.
In this study, it will assess the following muscles: hip flexors and extensors, knee flexors and extensors, ankle dorsiflexors and plantar flexors; shoulder flexors and extensors, elbow flexors and extensors, wrist flexors and extensors.
The instrument categorizes spasticity into six different grades, ranging from "0" (normal muscle tone) to "4" (joint rigidity in flexion or extension).
The lower the score, the less spasticity assessed.
|
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)
Time Frame: After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
|
The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better".
This scale has already been validated in Brazil and has been used in clinical practice assays with spinal cord injury.
|
After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 3, 2025
Primary Completion (Estimated)
November 10, 2025
Study Completion (Estimated)
November 10, 2025
Study Registration Dates
First Submitted
March 9, 2025
First Submitted That Met QC Criteria
March 14, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
March 14, 2025
Last Verified
March 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- tsDCS_physical therapy_iSCI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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