Spinal Cord InjurySLTNCT01962675
Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury
A study testing Transcranial direct current stimulation + step training in people with Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Transcranial direct current stimulation + step training
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Motor incomplete Spinal cord injured subjects.
- Ability to walk 10 m with or without walking aides.
- Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Who cannot join
- Seizures
- Cognitive function impairment
- Brain surgery or intracranial metal implants.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miami Project to Cure Paralysis
Miami, Florida, 33136
About this study
The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury.
Hypotheses H1: Participants will display greater improvement in stepping function following tDCS combined with training compared to sham-tDCS and training.
Read more
H2: Participants will display greater gains in cortical excitability, as evidenced by lower cortico-motor threshold (MT) associated with the TA muscles following tDCS and training compared to following sham stimulation and training.
H3: Participants in the tDCS+training group will show greater increases walking speed in a timed 10 meter walking trial.
H4: Participants in the tDCS+training group will show be able to perform a greater number of toe-taps test.
Read the detailed description
An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle.
In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing.
Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders.
Purpose of this research study:
The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI.
Studies have shown that non-invasive transcranial direct current stimulation (tDCS) can increase activity in specific cortical areas associated with motor learning, and therefore improve on the cortical and functional effects associated with motor practice training in individuals with SCI. If brain stimulation in combination with motor training is found to enhance improvements in control more effectively than motor training alone, this would provide a basis for further examining stimulation combined with lower limb joint therapy in individuals with spinal cord injury.
Objectives: To Assess improvements in lower extremity motor control that are associated with bilateral tDCS and functional motor training or sham tDCS and functional motor training in individuals with motor incomplete spinal cord injury.
- Conditions
- Spinal Cord Injury
- Being tested
- Transcranial direct current stimulation + step training, Sham transcranial direct current stimulation + step training
- Keywords
- tDCS, motor training, SCI
- 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.
Transcranial direct current stimulation + step trainingDevice
Direct current stimulation of motor cortex with low stimulation intensity
Sham transcranial direct current stimulation + step trainingBehavioural
Also called Stepping training
Stepping over specified soft foam obstacles
| Study group | Role | What they receive |
|---|---|---|
| tDCS and skilled training | Experimental | tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Receives: Device: Transcranial direct current stimulation + step training; Behavioral: Sham transcranial direct current stimulation + step training |
| Sham tDCS and skilled leg training | Sham comparator | Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training Receives: Behavioral: Sham transcranial direct current stimulation + step training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline Midswing Ankle ROM
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Measured: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Change From Baseline Active Motor Threshold
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
Measured: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Secondary outcomes (2)
Change From Baseline Scores of a 10 m Walk Test
Change from baseline score of the time required to perform 10 m walking.
Measured: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Change From Baseline Score on Toe Tap Test
Measuring the Time required to perform toe taps
Measured: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study startJul 2013
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: PI left study institution, declined to continue study at new institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Edelle Field-Fote, University of Miami
- Investigators
- Edelle C Field Fote, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962675
- Sponsor's protocol ID
- 20110344
- Acronym
- SLT
- Status last verified
- Nov 2015
- First submitted
- 30 Sep 2013
- Last updated
- 16 Nov 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT01962675
- Acronym / sponsor ID
- SLT / 20110344
- Conditions
- Spinal Cord Injury
- Keywords
- tDCS, motor training, SCI
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI left study institution, declined to continue study at new institution
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Posted 16 Nov 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury.
Hypotheses H1: Participants will display greater improvement in stepping function following tDCS combined with training compared to sham-tDCS and training.
H2: Participants will display greater gains in cortical excitability, as evidenced by lower cortico-motor threshold (MT) associated with the TA muscles following tDCS and training compared to following sham stimulation and training.
H3: Participants in the tDCS+training group will show greater increases walking speed in a timed 10 meter walking trial.
H4: Participants in the tDCS+training group will show be able to perform a greater number of toe-taps test.
Detailed description
An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle.
In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing.
Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders.
Purpose of this research study:
The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI.
Studies have shown that non-invasive transcranial direct current stimulation (tDCS) can increase activity in specific cortical areas associated with motor learning, and therefore improve on the cortical and functional effects associated with motor practice training in individuals with SCI. If brain stimulation in combination with motor training is found to enhance improvements in control more effectively than motor training alone, this would provide a basis for further examining stimulation combined with lower limb joint therapy in individuals with spinal cord injury.
Objectives: To Assess improvements in lower extremity motor control that are associated with bilateral tDCS and functional motor training or sham tDCS and functional motor training in individuals with motor incomplete spinal cord injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS and skilled training | Experimental | Device: Transcranial direct current stimulation + step training, Behavioral: Sham transcranial direct current stimulation + step trainingtDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training |
| Sham tDCS and skilled leg training | Sham comparator | Behavioral: Sham transcranial direct current stimulation + step trainingSham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Motor incomplete Spinal cord injured subjects.
- Ability to walk 10 m with or without walking aides.
- Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.
Key exclusion criteria (3 listed)
- Seizures
- Cognitive function impairment
- Brain surgery or intracranial metal implants.
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 |
|---|---|---|
| Transcranial direct current stimulation + step trainingDirect current stimulation of motor cortex with low stimulation intensity | Device | tDCS and skilled training |
| Sham transcranial direct current stimulation + step trainingAlso: Stepping trainingStepping over specified soft foam obstacles | Behavioural | Sham tDCS and skilled leg training, tDCS and skilled training |
Primary outcome
Change From Baseline Midswing Ankle ROM
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Change From Baseline Active Motor Threshold
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
2 secondary outcomes
Change From Baseline Scores of a 10 m Walk Test
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Change From Baseline Score on Toe Tap Test
Time frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Edelle C Field Fote, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation + step training in people with Spinal Cord Injury, run by University of Miami at 1 site in United States.
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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Nov 2015. 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 United States. 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?
Yes. Results are posted in the registry (first posted 16 Nov 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change From Baseline Midswing Ankle ROM (time frame: Two times, 1) Baseline, and 2) Up to 1 hour after 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 16 Nov 2015.