Spinal Cord InjuriesPhase 2NCT03394560
rTMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury
A Phase 2 study testing High frequency repetitive transcranial magnetic stimulation in people with Spinal Cord Injuries, run by Universidade Federal de Pernambuco at 1 site in Brazil.
Trial summary
The aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- High frequency repetitive transcranial magnetic 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
- 30 Jan 2018to 31 Jan 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- Presented clinical diagnostic of incomplete thoraco-lumbar spinal cord injury, provided by a neurologist (below the T1 level).
- Duration injury of at least 8 months.
- Presented degree of C or D according to the ASIA Impairment Scale (AIS) scale of the American Spinal Cord Injury Association.
- Patients who are not community walkers.
Who cannot join
- Pregnant women;
- Pacemaker;
- Historic of seizures;
- Metallic implants in the head;
- Patients with clinical evidence of brain injuries;
- Patients with neurological and / or orthopedic pathologies that have repercussion on a gait and the disadvantages
- Use of neuroleptic medications.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Applied Neuroscience Laboratory
Recife, Pernambuco, 50670-900
Fernanda N Nogueira, PT, + 55 81 99989 2636, fernandanrn@hotmail.com
Marina F Berenguer, PT, +55 81 99745 6028, marinaberenguer@hotmail.com
About this study
Official title: Repetitive Transcranial Magnetic Stimulation Combined to Body Weight-support Treadmill Training in the Sensory-motor Recovery of Patients With Chronic Incomplete Spinal Cord Injury
The aim of this study is to verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.
Read the detailed description
A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions). Active or sham rTMS will be combined with body weight-support treadmill training to verify the improvement of sensory-motor function in patients with incomplete spinal cord injury. Behavioral assessments will be performed before, after 6 and 12 therapeutic sessions and at the 30-day follow-up after the intervention, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).
- Conditions
- Spinal Cord Injuries
- Being tested
- High frequency repetitive transcranial magnetic stimulation, Sham High frequency repetitive transcranial magnetic stimulation
- Keywords
- Spinal Cord Injury, transcranial magnetic stimulation, body weight-support treadmill training, gait
- 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.
High frequency repetitive transcranial magnetic stimulationDevice
Also called Body Weight-support Treadmill Training
Gait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes.
Sham High frequency repetitive transcranial magnetic stimulationDevice
Also called Body Weight-support Treadmill Training
Gait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes.
| Study group | Role | What they receive |
|---|---|---|
| high-frequency rTMS + BWSTT | Experimental | a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month. Receives: Device: High frequency repetitive transcranial magnetic stimulation |
| sham rTMS + BWSTT | Sham comparator | a randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month. Receives: Device: Sham High frequency repetitive transcranial magnetic stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
this is international scale, designed to identify an improvement in the ability to perform gait with spinal cord injury under environmental conditions. The WISCI-II is considered standard for gait evaluation of patients with spinal cord injury inserted in clinical trials. The WISCI-II categorizes patients' ability to perform a gait on 20 different levels by considering the following: distance traveled, need for assistance, assistance from others people, and gait devices.
Measured: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.
Changes on ASIA 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, according to sensory-motor preservation, passing through 3 degrees of spinal cord injury (A , B, C, D or E).
Measured: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention.
Secondary outcomes (5)
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).
Measured: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
Change from Modified Ashworth scale (MAS)
Modified Ashworth scale uses a 6-point scale to score the average resistance to passive for movement each joint. In this study, it will assess muscles: flexors and extensors hip, flexors and extensors knee, dorsiflexors and plantar flexors ankle.
Measured: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.
Changes on Short-Form Health Survey (SF-36)
The SF-36 is a multidimensional questionnaire consisting of 36 items, encompassed in eight scales or components: i. Functional capacity - 10 items, ii. Limitation by physical resources - 4 items, iii. Pain - 2 items, iv. General health status - 5 items, v. Vitality - 4 items, vi. Social Aspects - 2 items, vii. Limitation by emotional aspects - 3 items, viii. Mental Health - 5 items and one comparative question more for assessment between how current health conditions and a year ago.
Measured: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
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: (i)T0 - after 2 weeks, (ii) T1- after 4 weeks and (iii) T2 - 1 month after the end of the intervention.
Changes on Lower Extremities Motor Scale (LEMS) from ASIA
It is international scale, the LEMS is composed from the sum of muscle function grading of the five key muscles of the lower limbs (hip flexors, knee extensors, long toe extensors, ankle dorsiflexors and ankle plantar flexors) of ASIA. The score of each muscle can graded from "0" to "5" and the total LEMS score can graded from "0 to 50", for this, it should be added the score of the five muscles of each lower limb (left and right).
Measured: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2018
- Study start30 Jan 2018 (estimated)
- Primary completion30 Aug 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, 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
- Investigators
- Lívia S Nascimento, MSc, Study chair, Applied Neuroscience LaboratoryMarina Berenguer, PT, Study chair, Applied Neuroscience Laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03394560
- Sponsor's protocol ID
- rTMS_BWSTT_SCI
- Status last verified
- Jan 2018
- First submitted
- 22 Dec 2017
- Last updated
- 9 Jan 2018
- 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 9 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repetitive Transcranial Magnetic Stimulation Combined to Body Weight-support Treadmill Training in the Sensory-motor Recovery of Patients With Chronic Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03394560
- Acronym / sponsor ID
- rTMS_BWSTT_SCI
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, transcranial magnetic stimulation, body weight-support treadmill training, gait
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universidade Federal de PernambucoUniversity, hospital or other
- Study start
- 30 Jan 2018 (estimated)
- Primary completion
- 30 Aug 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 9 Jan 2018 (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 verify the efficacy of body weight-support treadmill training combined with high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury.
Detailed description
A randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions). Active or sham rTMS will be combined with body weight-support treadmill training to verify the improvement of sensory-motor function in patients with incomplete spinal cord injury. Behavioral assessments will be performed before, after 6 and 12 therapeutic sessions and at the 30-day follow-up after the intervention, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-frequency rTMS + BWSTT | Experimental | Device: High frequency repetitive transcranial magnetic stimulationa randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three times a week for a month. |
| sham rTMS + BWSTT | Sham comparator | Device: Sham High frequency repetitive transcranial magnetic stimulationa randomized, sham-controlled, double-blinded and parallel group trial (12 therapeutic sessions) with the combination between body weight-support treadmill training combined and high-frequency rTMS in improving the sensory-motor function of adult patients with chronic incomplete thoracolumbar spinal cord injury. The sessions will be performed three 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 (4 listed)
- Presented clinical diagnostic of incomplete thoraco-lumbar spinal cord injury, provided by a neurologist (below the T1 level).
- Duration injury of at least 8 months.
- Presented degree of C or D according to the ASIA Impairment Scale (AIS) scale of the American Spinal Cord Injury Association.
- Patients who are not community walkers.
Key exclusion criteria (7 listed)
- Pregnant women;
- Pacemaker;
- Historic of seizures;
- Metallic implants in the head;
- Patients with clinical evidence of brain injuries;
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 |
|---|---|---|
| High frequency repetitive transcranial magnetic stimulationAlso: Body Weight-support Treadmill TrainingGait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes. | Device | high-frequency rTMS + BWSTT |
| Sham High frequency repetitive transcranial magnetic stimulationAlso: Body Weight-support Treadmill TrainingGait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes. | Device | sham rTMS + BWSTT |
Primary outcome
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)
Time frame: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.
this is international scale, designed to identify an improvement in the ability to perform gait with spinal cord injury under environmental conditions. The WISCI-II is considered standard for gait evaluation of patients with spinal cord injury inserted in clinical trials. The WISCI-II categorizes patients' ability to perform a gait on 20 different levels by considering the following: distance traveled, need for assistance, assistance from others people, and gait devices.
Changes on ASIA Impairment Scale (AIS)
Time frame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention.
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, according to sensory-motor preservation, passing through 3 degrees of spinal cord injury (A , B, C, D or E).
5 secondary outcomes
Changes on Spinal cord independence measure (Self-Reported) III (SCIM-III)
Time frame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
Change from Modified Ashworth scale (MAS)
Time frame: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.
Changes on Short-Form Health Survey (SF-36)
Time frame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
Changes on Patient Global Impression of Change Scale - (PGICS)
Time frame: (i)T0 - after 2 weeks, (ii) T1- after 4 weeks and (iii) T2 - 1 month after the end of the intervention.
Changes on Lower Extremities Motor Scale (LEMS) from ASIA
Time frame: (i) Baseline - one day before the intervention, (ii) T1- after 4 weeks and (iv) T2 - 1 month after the end of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2018.
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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. This study is not recruiting at the moment.
Lívia S Nascimento, MSc study chair
Applied Neuroscience Laboratory
Marina Berenguer, PT study chair
Applied Neuroscience Laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High frequency repetitive transcranial magnetic stimulation in people with Spinal Cord Injuries, 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 4 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 9 Jan 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kátia Monte-Silva, PhD (+55 81 2126-7579, monte.silvakk@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes on Walking Index for Spinal Cord Injury II (WISCI-II) (time frame: (i) Baseline - one day before the intervention, (ii) T0 - after 2 weeks, (iii) T1- after 4 weeks (iv) T2 - 1 month after the end of the intervention.). The study lists 2 primary outcomes in all. 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 9 Jan 2018.