Spinal Cord InjuriesPhase 3NCT03555838
Combined Robotic Training and tDCS in Chronic SCI
A Phase 3 study testing transcranial direct current stimulation in people with Spinal Cord Injuries and Tetraplegia, run by Burke Medical Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and understand the mechanisms of this interaction and its relationship to functional outcome. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Spinal Cord Injuries, Tetraplegia
- What is being tested?
- transcranial direct current stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2017to 1 Dec 2023
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand (ability to pick up at least 1 block on the Box and Blocks Test)
- Motor incomplete lesion (measured by the ASIA Impairment Scale, B, C, D)
- Chronic lesion (>6 months after the injury)
Who cannot join
- Motor and sensory complete lesion (AIS A)
- Presence of potential risk factor for brain stimulation (TMS and tDCS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
- History of head trauma and/or cognitive deficit
- Medically unstable
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this study
Official title: Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS
The purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and understand the mechanisms of this interaction and its relationship to functional outcome. The investigators hypothesize that supplementary tDCS will augment the functional improvement from robot-training, in chronic SCI.
Read the detailed description
Study design: Using a within-subjects repeated measures design, up to 40 SCI participants will be randomized to receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham (3 sessions/week, 18 sessions total). Clinical and functional scales, robotic kinematics and neurophysiological data (TMS evaluation) will be collected before and after the combined intervention period, and a month later (pre, post and follow up evaluations). Randomization will be done using a randomized block design with a block size of 2. All participants, raters, and experimenters will be blinded to treatment allocation.
AIM 1. To determine whether combining non-invasive brain stimulation (tDCS) and behavioral training (robotics) in SCI can lead to functional improvement. The investigators hypothesize that the group receiving the real stimulation will obtain a greater clinical improvement in hand motor function. Using a within subjects repeated measures design, baseline clinical hand function (Box and Blocks test) will be compared to post 6-week robotic training intervention, and then a month later (follow up), each session preceded by real (2mA anodal M1) or sham tDCS.
AIM 2. To examine the kinematic changes (from robotic measures) associated with the combined training. Quantitative measurements obtained from robotics are highly sensitive, precise and reliable. The investigators predict an enhancement of motor performance in all participants, measured by 5 key parameters: mean speed, peak speed, smoothness, aim and deviation; with greater improvements in the intervention group receiving the pre-conditioning effect of transcranial stimulation. These data will identify features of motor control that underlie improvements in clinical function, when comparing the two intervention groups.
AIM 3. To identify and compare the neurophysiological mechanisms (by TMS) associated with the combined training. The relationship between clinical improvement in neurophysiological measures pertaining to robotic motor training alone and combined with tDCS will be assessed. Measuring changes in MEP amplitude of hand muscles before and after the training will establish a) the plasticity associated with training alone and with supplementary brain stimulation, b) the neurophysiological characteristics of patients who respond better to the training. By understanding how brain excitability changes underpin motor dysfunction, and motor recovery, interventions can be more effectively prescribed and prognoses established.
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Being tested
- transcranial direct current stimulation, sham transcranial direct current stimulation
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationOther
Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head.
sham transcranial direct current stimulationOther
an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Participants in this arm will receive 20 minutes of 2 mA transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training. Receives: Other: transcranial direct current stimulation |
| Sham tDCS | Sham comparator | Participants in this arm will receive 20 minutes of sham transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training. Receives: Other: sham transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Box and Blocks Test
A timed functional test to determine gross manual dexterity
Measured: Baseline, immediately post-intervention, and 1 month follow up
Secondary outcomes (6)
Upper Extremity Motor Score
Manual muscle test of arm muscles; Score range from 0= no movement to 5= normal movement.
Measured: Baseline, immediately post-intervention, and 1 month follow up
Spinal Cord Independence Measure (SCIM III)
Evaluates patient's ability to complete activities of daily living; 19 questions in 3 domains; Scored 0 (severely impaired) -100 (independent)
Measured: Baseline, immediately post-intervention, and 1 month follow up
Modified Ashworth Scale
Measures spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.
Measured: Baseline, immediately post-intervention, and 1 month follow up
Nine Hole Peg Test
Timed measure of fine motor skills and dexterity
Measured: Baseline, immediately post-intervention, and 1 month follow up
Questionnaire of von Korff et al Grading the Severity of Chronic Pain
Self-evaluation of pain; 7 questions in total; 0= no pain, 100= severe pain
Measured: Baseline, immediately post-intervention, and 1 month follow up
Quadraplegia Index of Function- Short Form
Global function scale; 6 items dcored on a 5 point scale from 0 (dependent) to 4 (independent).
Measured: Baseline, immediately post-intervention, and 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2018
- Study start1 May 2017
- Primary completion1 Jan 2019
- Study completion1 Dec 2023 (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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Within-subjects repeated measures design up to 40 SCI participants will be randomized to receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham (3 sessions/week, 18 sessions total). Randomization will be done using a randomized block design with a block size of 2.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Burke Medical Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- New York State Spinal Cord Injury Research Board (SCIRB)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03555838
- Sponsor's protocol ID
- BRC549
- Status last verified
- Feb 2022
- First submitted
- 15 May 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: There is no plan to make individual participant data available to other researchers at this time.
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS
- ClinicalTrials.gov ID
- NCT03555838
- Acronym / sponsor ID
- BRC549
- Conditions
- Spinal Cord Injuries, Tetraplegia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Burke Medical Research InstituteUniversity, hospital or other
- Collaborators
- New York State Spinal Cord Injury Research Board (SCIRB)
- Study start
- 1 May 2017 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 14 Jun 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 purpose of this study is to establish the value of combined non-invasive stimulation (tDCS) and behavioral training (robotics) in SCI rehabilitation, and understand the mechanisms of this interaction and its relationship to functional outcome. The investigators hypothesize that supplementary tDCS will augment the functional improvement from robot-training, in chronic SCI.
Detailed description
Study design: Using a within-subjects repeated measures design, up to 40 SCI participants will be randomized to receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham (3 sessions/week, 18 sessions total). Clinical and functional scales, robotic kinematics and neurophysiological data (TMS evaluation) will be collected before and after the combined intervention period, and a month later (pre, post and follow up evaluations). Randomization will be done using a randomized block design with a block size of 2. All participants, raters, and experimenters will be blinded to treatment allocation.
AIM 1. To determine whether combining non-invasive brain stimulation (tDCS) and behavioral training (robotics) in SCI can lead to functional improvement. The investigators hypothesize that the group receiving the real stimulation will obtain a greater clinical improvement in hand motor function. Using a within subjects repeated measures design, baseline clinical hand function (Box and Blocks test) will be compared to post 6-week robotic training intervention, and then a month later (follow up), each session preceded by real (2mA anodal M1) or sham tDCS.
AIM 2. To examine the kinematic changes (from robotic measures) associated with the combined training. Quantitative measurements obtained from robotics are highly sensitive, precise and reliable. The investigators predict an enhancement of motor performance in all participants, measured by 5 key parameters: mean speed, peak speed, smoothness, aim and deviation; with greater improvements in the intervention group receiving the pre-conditioning effect of transcranial stimulation. These data will identify features of motor control that underlie improvements in clinical function, when comparing the two intervention groups.
AIM 3. To identify and compare the neurophysiological mechanisms (by TMS) associated with the combined training. The relationship between clinical improvement in neurophysiological measures pertaining to robotic motor training alone and combined with tDCS will be assessed. Measuring changes in MEP amplitude of hand muscles before and after the training will establish a) the plasticity associated with training alone and with supplementary brain stimulation, b) the neurophysiological characteristics of patients who respond better to the training. By understanding how brain excitability changes underpin motor dysfunction, and motor recovery, interventions can be more effectively prescribed and prognoses established.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Within-subjects repeated measures design up to 40 SCI participants will be randomized to receive 6-week hand robotic training preceded by 20 min anodal 2mA tDCS or sham (3 sessions/week, 18 sessions total). Randomization will be done using a randomized block design with a block size of 2.
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Other: transcranial direct current stimulationParticipants in this arm will receive 20 minutes of 2 mA transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training. |
| Sham tDCS | Sham comparator | Other: sham transcranial direct current stimulationParticipants in this arm will receive 20 minutes of sham transcranial direct current stimulation over the primary motor cortex of the more affected arm prior to robotic training. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Tetraplegia (cervical lesion) with some degree of motor dysfunction in the hand (ability to pick up at least 1 block on the Box and Blocks Test)
- Motor incomplete lesion (measured by the ASIA Impairment Scale, B, C, D)
- Chronic lesion (>6 months after the injury)
Key exclusion criteria (4 listed)
- Motor and sensory complete lesion (AIS A)
- Presence of potential risk factor for brain stimulation (TMS and tDCS): history of seizures, presence of surgically implanted foreign bodies such as a pacemaker, metal plate in the skull, and metal inside the skull
- History of head trauma and/or cognitive deficit
- Medically unstable
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 stimulationTranscranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head. | Other | Active tDCS |
| sham transcranial direct current stimulationan inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes. | Other | Sham tDCS |
Primary outcome
Change in Box and Blocks Test
Time frame: Baseline, immediately post-intervention, and 1 month follow up
A timed functional test to determine gross manual dexterity
6 secondary outcomes
Upper Extremity Motor Score
Time frame: Baseline, immediately post-intervention, and 1 month follow up
Spinal Cord Independence Measure (SCIM III)
Time frame: Baseline, immediately post-intervention, and 1 month follow up
Modified Ashworth Scale
Time frame: Baseline, immediately post-intervention, and 1 month follow up
Nine Hole Peg Test
Time frame: Baseline, immediately post-intervention, and 1 month follow up
Questionnaire of von Korff et al Grading the Severity of Chronic Pain
Time frame: Baseline, immediately post-intervention, and 1 month follow up
Quadraplegia Index of Function- Short Form
Time frame: Baseline, immediately post-intervention, and 1 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Individual participant dataSharing planned: Undecided. There is no plan to make individual participant data available to other researchers at this time.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transcranial direct current stimulation in people with Spinal Cord Injuries and Tetraplegia, run by Burke Medical Research Institute 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 4 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 2 Mar 2022. 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.
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?
Results are not available in the source record.
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 in Box and Blocks Test (time frame: Baseline, immediately post-intervention, and 1 month follow up). 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 2 Mar 2022.