Functional ImprovementPhase 3SCINCT02711319
Non-invasive Brain Stimulation for Gait Improvement in Patients With Spinal Cord Injury
A Phase 3 study testing rTMS in people with Functional Improvement, run by Institut Guttmann.
Trial summary
to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to gait training in Lokomat®). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Functional Improvement
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Aug 2015
- Phase
- Phase 3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- had subacute motor incomplete SCI (AIS-C or D),
- candidate for gait rehabilitation with Lokomat® after cervical or thoracic SCI;
- stable medical treatment at least one week before and during the study;
- without limitation of passive range of movement in joints
- agreed to participate after signing a written informed consent form.
Who cannot join
- unstable clinical state
- severe spasticity (MAS>=3)
- disagreed to sign consent form
About this study
Official title: Non-invasive Brain Stimulation in SCI
to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger improvement of gait function than with physical therapy alone.
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive and painless procedure to modulate cortical excitability of motor areas and induce changes over the descending corticospinal output. This modulation may be useful to promote active recovery of motor function and to obtain functional benefit from gait rehabilitation. Through the use of repetitive high-frequency rTMS, improvement has been reported in motor and sensory functions measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), and time to complete a peg-board task in four chronic incomplete cervical SCI patients.
Physical therapy aims to improve function of both undamaged and also, as far as possible, damaged neuronal structures. However, 'reorganization' of neuronal circuits is the target of specific training approaches. Therefore, the challenge is to guide CNS plasticity in order to optimize the functional outcome for a given individual. Hypothesized was that high-frequency rTMS coupled with gait training can improve motor recovery in the lower extremities and locomotion in incomplete SCI patients to a greater degree than sham stimulation.
- Conditions
- Functional Improvement
- Being tested
- rTMS, sham rTMS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
Also called active rTMS, active group, real rTMS
For real (active) rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes
sham rTMSDevice
Also called sham group, placebo group
Sham Comparator: sham rTMS (SHAM GROUP)
For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2).
| Study group | Role | What they receive |
|---|---|---|
| active (real) rTMS (ACTIVE GROUP) | Active comparator | The patients were randomly distributed in two study groups: real or sham rTMS group.
For real rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes. Receives: Device: rTMS |
| sham rTMS (SHAM GROUP) | Sham comparator | For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2). Receives: Device: sham rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)
Patients with or without orthesis were asked to walk at their fastest but most comfortable speed and step length and cadence assessed during the 10MWT (We added the number of steps taken in 10 m. Step length (meters)=distance (m) x 2 / number of stops (heel to heel of same foot). Cadence (steps/min.)=number of steps x 60 / time (seconds))
Measured: Change from Baseline 10MWT at 4 and 8 weeks
Secondary outcomes (3)
Modified Ashworth Scale (MAS)
Tests resistance to passive movement about a joint with varying degrees of velocity at knees
Measured: Change from Baseline MAS at 4 weeks
--Total motor score from upper (UEMS) and lower extremities (LEMS)
Total motor score from upper (UEMS) (score 50points) and lower extremities (LEMS) (score 50points) obtained from the standardized AIS clinical exam (total score=100)
Measured: Change from Baseline 1UEMS and LEMS at 4 and 8 weeks
Walking Index for SCI (WISCI) II
The ranking of severity of gait is based on the severity of the impairment and not on functional independence in the environment.
Measured: Change from Baseline WISCI-II at 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study startDec 2010
- Primary completionJun 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional ImprovementStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Guttmann
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Joan Vidal, Institut Guttmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02711319
- Sponsor's protocol ID
- PI10/00442
- Acronym
- SCI
- Status last verified
- Feb 2016
- First submitted
- 9 Mar 2016
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Brain Stimulation in SCI
- ClinicalTrials.gov ID
- NCT02711319
- Acronym / sponsor ID
- SCI / PI10/00442
- Conditions
- Functional Improvement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Institut GuttmannUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Dec 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 17 Mar 2016 (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.
to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger improvement of gait function than with physical therapy alone.
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive and painless procedure to modulate cortical excitability of motor areas and induce changes over the descending corticospinal output. This modulation may be useful to promote active recovery of motor function and to obtain functional benefit from gait rehabilitation. Through the use of repetitive high-frequency rTMS, improvement has been reported in motor and sensory functions measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), and time to complete a peg-board task in four chronic incomplete cervical SCI patients.
Physical therapy aims to improve function of both undamaged and also, as far as possible, damaged neuronal structures. However, 'reorganization' of neuronal circuits is the target of specific training approaches. Therefore, the challenge is to guide CNS plasticity in order to optimize the functional outcome for a given individual. Hypothesized was that high-frequency rTMS coupled with gait training can improve motor recovery in the lower extremities and locomotion in incomplete SCI patients to a greater degree than sham stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| active (real) rTMS (ACTIVE GROUP) | Active comparator | Device: rTMSThe patients were randomly distributed in two study groups: real or sham rTMS group. For real rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes. |
| sham rTMS (SHAM GROUP) | Sham comparator | Device: sham rTMSFor sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2). |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- had subacute motor incomplete SCI (AIS-C or D),
- candidate for gait rehabilitation with Lokomat® after cervical or thoracic SCI;
- stable medical treatment at least one week before and during the study;
- without limitation of passive range of movement in joints
- agreed to participate after signing a written informed consent form.
Key exclusion criteria (3 listed)
- unstable clinical state
- severe spasticity (MAS>=3)
- disagreed to sign consent form
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 |
|---|---|---|
| rTMSAlso: active rTMS, active group, real rTMSFor real (active) rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes | Device | active (real) rTMS (ACTIVE GROUP) |
| sham rTMSAlso: sham group, placebo groupSham Comparator: sham rTMS (SHAM GROUP) For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2). | Device | sham rTMS (SHAM GROUP) |
Primary outcome
ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)
Time frame: Change from Baseline 10MWT at 4 and 8 weeks
Patients with or without orthesis were asked to walk at their fastest but most comfortable speed and step length and cadence assessed during the 10MWT (We added the number of steps taken in 10 m. Step length (meters)=distance (m) x 2 / number of stops (heel to heel of same foot). Cadence (steps/min.)=number of steps x 60 / time (seconds))
3 secondary outcomes
Modified Ashworth Scale (MAS)
Time frame: Change from Baseline MAS at 4 weeks
--Total motor score from upper (UEMS) and lower extremities (LEMS)
Time frame: Change from Baseline 1UEMS and LEMS at 4 and 8 weeks
Walking Index for SCI (WISCI) II
Time frame: Change from Baseline WISCI-II at 4 and 8 weeks
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 17 Mar 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing rTMS in people with Functional Improvement, run by Institut Guttmann.
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 5 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: finished, as of the sponsor's last update on 17 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
ten-meters walking test (10MWT=Time in seconds to walk 10 meters.) (time frame: Change from Baseline 10MWT at 4 and 8 weeks). 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 17 Mar 2016.