Spinal Cord InjuryNCT06886386
TsDCS and Physical Therapy After Incomplete Spinal Cord Injury
A study testing Trans-spinal direct current stimulation in people with Spinal Cord Injury, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Trans-spinal direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Mar 2025to 10 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of incomplete spinal cord injury by a neurologist
- Diagnosis time greater than 12 months
Who cannot join
- Patients with additional current neurological diagnoses
- Presence of contraindications for tsDCS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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
- Being tested
- Trans-spinal direct current stimulation
- Keywords
- trans-spinal direct current stimulation, physical therapy, spinal cord injury, motor function
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans-spinal direct current stimulationDevice
Also called Physical therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Trans-spinal direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: After 10 sessions (10 days of intervention) and one month (30 days) following the completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start3 Mar 2025
- Primary completion10 Nov 2025 (estimated)
- Study completion10 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernanda Natacha Rufino Nogueira, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886386
- Sponsor's protocol ID
- tsDCS_physical therapy_iSCI
- Status last verified
- Mar 2025
- First submitted
- 9 Mar 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Trans-spinal Direct Current Stimulation Combined to Physical Therapy in Patients with Chronic Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06886386
- Acronym / sponsor ID
- tsDCS_physical therapy_iSCI
- Conditions
- Spinal Cord Injury
- Keywords
- trans-spinal direct current stimulation, physical therapy, spinal cord injury, motor function
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 3 Mar 2025 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 10 Nov 2025 (estimated)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active tsDCS + physical therapy | Experimental | Device: Trans-spinal direct current stimulationa 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. |
| sham tsDCS + physical therapy | Sham comparator | Device: Trans-spinal direct current stimulationa 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of incomplete spinal cord injury by a neurologist
- Diagnosis time greater than 12 months
Key exclusion criteria (2 listed)
- Patients with additional current neurological diagnoses
- Presence of contraindications for tsDCS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trans-spinal direct current stimulationAlso: Physical therapyPatients 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. | Device | active tsDCS + physical therapy, sham tsDCS + physical therapy |
Primary outcome
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.
4 secondary outcomes
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trans-spinal direct current stimulation in people with Spinal Cord Injury, run by Universidade Federal de Pernambuco at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.