Spinal Cord InjuriesNCT02562001
Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury
A study testing Outpatient active group and Inpatient active group in people with Spinal Cord Injuries, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Outpatient active group and Inpatient active group
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 6 May 2015to 5 May 2018
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin;
- 1 to 36 months of lesion;
- ASIA C and D;
- Stable clinical status;
- Cognitive function preserved in order to understand and execute the experiment and follow the instructions (Wechsler Adult Intelligence Scale - WASI 2014);
- Written informed consent;
- Tolerance to sit upright for at least 1 hour.
Who cannot join
- Traumatic brain injury history, stroke, epilepsy and/or any other previous or concomitant neurological conditions to spinal cord injury;
- Presence of progressive neurodegenerative disease;
- Previous orthopedic problems (eg osteoarthritis, joint deformities);
- Member hypertonic (grade > 3 on the modified Ashworth scale);
- Active/passive joint range of motion limitations;
- Irreversible muscle contractures;
Show all 15Show fewer
- Lack of physical resistance during proposed physical training;
- Disabling fatigue;
- Body weight > 150 Kg;
- Osteoporosis with pathological fracture risk;
- Asymmetry in the lower limbs > 2 cm;
- Skin lesions and / or pressure ulcer in areas where the orthosis of Lokomat will press;
- Any other exclusion criteria established by medical decision.
- Skin lesions in the stimulation site; presence of electric, magnetic or mechanically activated implant (including cardiac pacemakers); intracerebral vascular clip or any other electrically sensitive device; pregnancy; metal in any part of the head; history of epilepsy resistant to medication; history of seizures or loss of consciousness not clarified and / or unaccompanied by a doctor.
- Cardiac pacemaker; unstable angina or other decompensated heart disease; decompensated chronic obstructive pulmonary disease; unchecked autonomic dysreflexia that hinders Lokomat training; unhealed fracture of the bones of the lower limbs; tracheostomy; deformities and stiffness of the hip joint, knee ( ≥ 20° flexion) and ankle ( ≥ 10° plantar flexion).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto de Medicina Física e Reabilitação, Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo
São Paulo, 04116-030
About this study
Official title: Association of Transcranial Direct Current Stimulation (tDCS) With Gait Training With Partial Body Weight Support on the Robotic Device (Lokomat) for Treatment of Patients With Incomplete Spinal Cord Injury
The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Our goal is to analyze the effects of electrical transcranial direct-current stimulation (tDCS) combined with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI). In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active tDCS presents an improvement over the ground gait after the Lokomat training period significantly greater than the placebo group, with relations between neurophysiologic, kinematics and functional measurements.
Read the detailed description
The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Therefore, our goal is to analyze the effects of the treatment with electrical transcranial direct-current stimulation (tDCS) associated with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI) classified as AIS C and D. In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active (tDCS) presents an improvement over the ground gait after the Lokomat training period, significantly greater than the placebo group, with positive correlation between neurophysiologic, kinematics and functional measurements.
- Conditions
- Spinal Cord Injuries
- Being tested
- Outpatient active group, Outpatient placebo group, Inpatient active group, Inpatient placebo group
- Keywords
- Spinal Cord Injuries, gait training, robotic, Lokomat, Transcranial Magnetic Stimulation, transcranial direct-current stimulation, Electroencephalography, Functional near-infrared spectroscopy
- 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.
Outpatient active groupDevice
Also called tDCS active
active tDCS during 20 minutes before Lokomat training for outpatients
Outpatient placebo groupDevice
Also called tDCS placebo
placebo tDCS during 20 minutes before Lokomat training for outpatients
Inpatient active groupDevice
Also called tDCS active
active tDCS during 20 minutes before Lokomat training for inpatients
Inpatient placebo groupDevice
Also called tDCS placebo
placebo tDCS during 20 minutes before Lokomat training for inpatients
| Study group | Role | What they receive |
|---|---|---|
| Outpatient active group | Experimental | This group will receive active tDCS, combined with Lokomat gait training Receives: Device: Outpatient active group |
| Inpatient active group | Experimental | This group will receive active tDCS, combined with Lokomat gait training Receives: Device: Inpatient active group |
| Outpatient placebo group | Experimental | This group will receive placebo tDCS, combined with Lokomat gait training Receives: Device: Outpatient placebo group |
| Inpatient placebo group | Experimental | This group will receive placebo tDCS, combined with Lokomat gait training Receives: Device: Inpatient placebo group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A. Change in the Walk Index for Spinal Cord Injury, WISCI II
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Secondary outcomes (20)
American Spinal Injury Association Impairment Scale - ASIA
Measured: pre (before treatment) [t0]
Change in the (Wechsler Adult Intelligence Scale - WASI 2014)
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Ashworth Modified Scale
Measured: pre (before treatment) [t0],inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Berg Balance Test
Measured: pre (before treatment) [t0],inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the 10 meters Walking Test and 6 Minutes Walking test
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Time Up and Go Test - TUG
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Short Form - 36 Quality of Life Test - SF 36
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Spinal Cord Independence Measure - SCIM
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Lower Extremity Isokinetic Dynamometry
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Change in the Visual Analogic Scale - VAS
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Brazilian version of the McGill Pain Questionnaire
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Pressure Algometer
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Conditioned Pain Modulation - CPM
Measured: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing)
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Hospital Anxiety and Depression Scale - HAD
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Beck Depression Inventory
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Patient Health Questionnaire 9 - PHQ 9
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Transcranial Magnetic Stimulation
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 optodes (48 channels)
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Change in the Electroencephalography
Measured: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2015 (estimated)
- Study start6 May 2015
- Primary completion5 May 2018
- Study completion5 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linamara Rizzo Battistella, MD PhD, University of Sao Paulo General Hospital
- Investigators
- Linamara Battistella, Md PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02562001
- Sponsor's protocol ID
- 43450715.7.0000.0068_CAAE
- Status last verified
- Jun 2021
- First submitted
- 30 Jul 2015
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Pai MYB, Terranova TT, Simis M, Fregni F, Battistella LR. The Combined Use of Transcranial Direct Current Stimulation and Robotic Therapy for the Upper Limb. J Vis Exp. 2018 Sep 23;(139):58495. doi: 10.3791/58495.
PubMed 30295660Simis M, Uygur-Kucukseymen E, Pacheco-Barrios K, Battistella LR, Fregni F. Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis. Clin Neurophysiol. 2020 Aug;131(8):1806-1814. doi: 10.1016/j.clinph.2020.04.166. Epub 2020 May 22.
PubMed 32540720
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Transcranial Direct Current Stimulation (tDCS) With Gait Training With Partial Body Weight Support on the Robotic Device (Lokomat) for Treatment of Patients With Incomplete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02562001
- Acronym / sponsor ID
- 43450715.7.0000.0068_CAAE
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injuries, gait training, robotic, Lokomat, Transcranial Magnetic Stimulation, transcranial direct-current stimulation, Electroencephalography, Functional near-infrared spectroscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- 6 May 2015 (actual)
- Primary completion
- 5 May 2018 (actual)
- Study completion
- 5 May 2018 (actual)
- First posted
- 29 Sep 2015 (estimated)
- 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 spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Our goal is to analyze the effects of electrical transcranial direct-current stimulation (tDCS) combined with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI). In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active tDCS presents an improvement over the ground gait after the Lokomat training period significantly greater than the placebo group, with relations between neurophysiologic, kinematics and functional measurements.
Detailed description
The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Therefore, our goal is to analyze the effects of the treatment with electrical transcranial direct-current stimulation (tDCS) associated with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI) classified as AIS C and D. In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active (tDCS) presents an improvement over the ground gait after the Lokomat training period, significantly greater than the placebo group, with positive correlation between neurophysiologic, kinematics and functional measurements.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Outpatient active group | Experimental | Device: Outpatient active groupThis group will receive active tDCS, combined with Lokomat gait training |
| Inpatient active group | Experimental | Device: Inpatient active groupThis group will receive active tDCS, combined with Lokomat gait training |
| Outpatient placebo group | Experimental | Device: Outpatient placebo groupThis group will receive placebo tDCS, combined with Lokomat gait training |
| Inpatient placebo group | Experimental | Device: Inpatient placebo groupThis group will receive placebo tDCS, combined with Lokomat gait training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical and radiological diagnosis of incomplete spinal cord injury of traumatic origin;
- 1 to 36 months of lesion;
- ASIA C and D;
- Stable clinical status;
- Cognitive function preserved in order to understand and execute the experiment and follow the instructions (Wechsler Adult Intelligence Scale - WASI 2014);
Key exclusion criteria (15 listed)
- Traumatic brain injury history, stroke, epilepsy and/or any other previous or concomitant neurological conditions to spinal cord injury;
- Presence of progressive neurodegenerative disease;
- Previous orthopedic problems (eg osteoarthritis, joint deformities);
- Member hypertonic (grade > 3 on the modified Ashworth scale);
- Active/passive joint range of motion limitations;
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 |
|---|---|---|
| Outpatient active groupAlso: tDCS activeactive tDCS during 20 minutes before Lokomat training for outpatients | Device | Outpatient active group |
| Outpatient placebo groupAlso: tDCS placeboplacebo tDCS during 20 minutes before Lokomat training for outpatients | Device | Outpatient placebo group |
| Inpatient active groupAlso: tDCS activeactive tDCS during 20 minutes before Lokomat training for inpatients | Device | Inpatient active group |
| Inpatient placebo groupAlso: tDCS placeboplacebo tDCS during 20 minutes before Lokomat training for inpatients | Device | Inpatient placebo group |
Primary outcome
A. Change in the Walk Index for Spinal Cord Injury, WISCI II
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
20 secondary outcomes
American Spinal Injury Association Impairment Scale - ASIA
Time frame: pre (before treatment) [t0]
Change in the (Wechsler Adult Intelligence Scale - WASI 2014)
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Ashworth Modified Scale
Time frame: pre (before treatment) [t0],inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Berg Balance Test
Time frame: pre (before treatment) [t0],inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the 10 meters Walking Test and 6 Minutes Walking test
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Time Up and Go Test - TUG
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Short Form - 36 Quality of Life Test - SF 36
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Spinal Cord Independence Measure - SCIM
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Lower Extremity Isokinetic Dynamometry
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Change in the Visual Analogic Scale - VAS
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Brazilian version of the McGill Pain Questionnaire
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Pressure Algometer
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Conditioned Pain Modulation - CPM
Time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Pain-Related Self-Statements Scale - Catastrophizing Subscale (PRSS-Catastrophizing)
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Hospital Anxiety and Depression Scale - HAD
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Beck Depression Inventory
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Patient Health Questionnaire 9 - PHQ 9
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]
Change in the Transcranial Magnetic Stimulation
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Change in the Functional Near-Infrared Spectroscopy - fNIRS 16 optodes (48 channels)
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Change in the Electroencephalography
Time frame: pre (before treatment) [t0], post (after treatment) [after 10 weeks GA and after 6 weeks GI]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Results publication: PubMed 30295660Pai MYB, Terranova TT, Simis M, Fregni F, Battistella LR. The Combined Use of Transcranial Direct Current Stimulation and Robotic Therapy for the Upper Limb. J Vis Exp. 2018 Sep 23;(139):58495. doi: 10.3791/58495.
- Results publication: PubMed 32540720Simis M, Uygur-Kucukseymen E, Pacheco-Barrios K, Battistella LR, Fregni F. Beta-band oscillations as a biomarker of gait recovery in spinal cord injury patients: A quantitative electroencephalography analysis. Clin Neurophysiol. 2020 Aug;131(8):1806-1814. doi: 10.1016/j.clinph.2020.04.166. Epub 2020 May 22.
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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.
Linamara Battistella, Md PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient active group and Inpatient active group in people with Spinal Cord Injuries, run by University of Sao Paulo General Hospital 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 7 inclusion and 15 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: finished, as of the sponsor's last update on 8 Jun 2021. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
A. Change in the Walk Index for Spinal Cord Injury, WISCI II (time frame: pre (before treatment) [t0], inter (after 15 sessions) [after 5 weeks GA and after 3 weeks GI], post (after treatment) [after 10 weeks GA and after 6 weeks GI] and 3 months follow up [after 22 weeks GA and after 18 weeks GI]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02562001, which also lists 2 linked publications.
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 8 Jun 2021.