Spinal Cord InjuriesPhase 2NCT06813287
Brain Monitoring, tDCS and Robotic Training in SCI
A Phase 2 study testing Electroencephalography (EEG) and Upper extremity robot in people with Spinal Cord Injuries, run by Kathleen Friel at 1 site in United States.
Trial summary
To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Electroencephalography (EEG) and Upper extremity robot
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2012to 27 Jun 2018
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Level of injury C5 to T1
- Chronic SCI > 6 months
- Tetraplegic with some degree of motor dysfunction in the upper limb
- Motor Incomplete/Complete
- Medically stable
Who cannot join
- < 6 month after injury
- History of head trauma and/or cognitive deficit
- History of stroke, seizures or other intracranial disease
- Medically unstable
- Concomitant neurological disorder
- Pre-existing medical conditions interfering with unrestricted movement of the hand/arm (e.g. osteoarthritis, injury to the joints)
Show all 14Show fewer
- Inability to provide informed consent
- Contraindications for non-invasive brain stimulation (NIBS) techniques (TMS \& tDCS)- see below.
- Non-Invasive Brain Stimulation Contraindications
- Surgically implanted foreign bodies such as a pacemaker, implanted medication pump, metal plate in the skull
- Metal inside the skull (other than dental appliances or fillings) that may pose a physical hazard during magnetic stimulation.
- No skin condition
- Any significant medical or psychiatric illness
- History of epilepsy
Trial locations and contacts
1 site in 1 country.
United States1 site
Burke Medical Research Institute
White Plains, New York, 10605
About this study
To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with upper-limb robotic therapy (Study 2), as well as to characterize the neurophysiological (TMS) and brain signaling (EEG) profile of patients and specific muscles that respond to the combination of neuromodulation and robotic motor training.
Read the detailed description
Current training interventions for rehabilitating patients with SCI are designed to provide the greatest possible restoration of function in the shortest possible time. One of the major deficits in our current approach to applying therapy is that we have little ability to predict which patients are most likely to respond to therapy or which muscle groups are most amenable to improvement. Transcranial magnetic stimulation (TMS) is a noninvasive method to excite or inhibit neurons in the brain or the spinal cord. Numerous studies have been using this technique to map connections from the motor cortex via the spinal cord to peripheral muscles; and as a therapeutic tool to promote useful plasticity.
The significance of the present study lies in the potential of intensive upper limb motor training with a novel robotic device, in conjunction with transcranial direct current stimulation (tDCS) over the contralateral motor cortex, may enhance neural recovery and upper limb function in patients with tetraplegia.
The robotic training devices represent the most sophisticated interactive rehabilitation systems available on the current market; they are additionally appealing for their ability to quantify various aspects of movement, and they appear to be particularly powerful way to promote functional recovery. Furthermore, robotic devices can be used in collection of quantitative data from the patients, which can be interpreted to analyze their rate of progress. Rehabilitation robots are capable of providing important components of motor skill learning and muscle training: individually prescribed intensity, repetition, and performance feedback. Furthermore, they are a novel and reliable method of assessing voluntary motor control. Our center has extensive experience in the use of rehabilitation robotics in the assessment and training of voluntary motor control in SCI patients, as well as other neurological disorders. From the investigator's previous experience using robotic therapy in SCI patients they can predict that some patients (approximately 10%) will show direct benefits from the interactive robot training.
The use of neuromodulatory techniques (TMS, tDCS) has been used for the last 2 decades in neurorehabilitation with the aim of enhance motor recovery when paired with activity dependent plasticity (training). In this proposal the investigator's will be using a new tDCS device, StarStim® - a wireless multichannel device that allows EEG recording as well as real or sham tDCS stimulation.
The purpose of this study is: To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with upper-limb robotic therapy (Study 2), as well as to characterize the neurophysiological (TMS) and brain signaling (EEG) profile of patients and specific muscles that respond to the combination of neuromodulation and robotic motor training.
Study 1, Objective: To evaluate changes in cortical neurophysiological and biological brain signaling after a single session of tDCS. The TMS responses of the upper limb muscles with lack of voluntary motor control will be assessed prior and after 20 min of tDCS intervention. Additionally, the investigators will record EEG activity before, during and after the intervention.
Study 2, Objective: To explore the accumulative effects of 2 weeks of tDCS + Robotic training in cortical excitability and brain signaling. In addition, the investigators will investigate whether the intensive robotic training in conjunction with tDCS over the contralateral motor cortex area will enhance neural recovery and upper limb function in patients with tetraplegia.
The investigators will compare two different brain stimulation protocols to assess the enhancement of the motor performance of those muscles that lack motor control, comparing the effects of 2-weeks intensive hand-robotic training with real or sham tDCS.
The investigators hypothesize that the patients who undergo real tDCS in conjunction with prolonged intense robotic training will achieve greater improvements in motor function and sensation compared to their counterparts who are in the sham control group.
- Conditions
- Spinal Cord Injuries
- Being tested
- Electroencephalography (EEG), Upper extremity robot
- 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.
Electroencephalography (EEG)Diagnostic test
Recording of electrical activity in the brain
Upper extremity robotDevice
Used for training and objective assessment (kinematics)
| Study group | Role | What they receive |
|---|---|---|
| tDCS & EEG | Experimental | 20 minutes of real anodal tDCS of cortical neurophysiology and EEG responses in chronic spinal cord injury patients. Receives: Diagnostic Test: Electroencephalography (EEG) |
| Sham tDCS | Sham comparator | 2 weeks (5x per week) of upper limb robotic training in conjunction with sham tDCS. Receives: Device: Upper extremity robot |
| Active tDCS | Experimental | 2 weeks (5x per week) of upper limb robotic training in conjunction with active tDCS. Receives: Device: Upper extremity robot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Threshold
The necessary stimulator output to evoke a response in the target muscle
Measured: Change in motor threshold from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.
Action Research Arm Test
Assessment of upper extremity motor improvements
Measured: Baseline, immediately after intervention.
Amplitude of Response
The size of the wave form (response) generated during motor threshold determination.
Measured: Change in amplitude from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.
Secondary outcomes (9)
Transcranial magnetic stimulation mapping
Method of determining a specific muscle's spatial representation in the cortex.
Measured: Baseline, immediately after intervention, and 1 month follow up
Electroencephalography (EEG) Recording
Assessment of electrical activity in the brain over a period of time, as determined non-invasively through electrodes placed on the head.
Measured: Baseline, immediately after intervention, and 1 month follow up
Muscle Strength Evaluation
Maximum voluntary contraction of the studied upper extremity muscle
Measured: Baseline, immediately after intervention, and 1 month follow up
Upper Extremity Motor Score (UEMS)
Measure of upper extremity strength
Measured: Baseline, immediately after intervention
Spinal Cord Independence Measure (SCIM III)
Measure of functional independence in activities of daily living
Measured: Baseline, immediately after intervention
Visual Analogue Scale
Used as a self-report of pain
Measured: Baseline, immediately after intervention
Quadriplegia Index of Function (QIF)
Quality of life scale
Measured: Baseline, immediately after intervention
Jebsen-Taylor Hand Function Test
Assessment of fine motor skills
Measured: Baseline, immediately after intervention
Motor Evoked Potential Facilitation
Method of assessing a nerves response to an external stimuli (transcranial magnetic stimulation)
Measured: Baseline, immediately after 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 posted6 Feb 2025
- Study start1 Nov 2012
- Primary completion31 Dec 2014
- Study completion27 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathleen Friel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Kathleen Friel, Burke Medical Research Institute
- Investigators
- Mar Cortes, MD, Principal investigator, Mt Sinai School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813287
- Sponsor's protocol ID
- BRC442
- Status last verified
- Feb 2025
- First submitted
- 17 May 2018
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available to other researchers at this time.
Publications
Barbeau H, Nadeau S, Garneau C. Physical determinants, emerging concepts, and training approaches in gait of individuals with spinal cord injury. J Neurotrauma. 2006 Mar-Apr;23(3-4):571-85. doi: 10.1089/neu.2006.23.571.
PubMed 16629638Behrman AL, Harkema SJ. Physical rehabilitation as an agent for recovery after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):183-202, v. doi: 10.1016/j.pmr.2007.02.002.
PubMed 17543768Krebs HI, Volpe B, Hogan N. A working model of stroke recovery from rehabilitation robotics practitioners. J Neuroeng Rehabil. 2009 Feb 25;6:6. doi: 10.1186/1743-0003-6-6.
PubMed 19243615Spooren AI, Janssen-Potten YJ, Kerckhofs E, Seelen HA. Outcome of motor training programmes on arm and hand functioning in patients with cervical spinal cord injury according to different levels of the ICF: a systematic review. J Rehabil Med. 2009 Jun;41(7):497-505. doi: 10.2340/16501977-0387.
PubMed 19543659Wirth B, Van Hedel HJ, Curt A. Changes in corticospinal function and ankle motor control during recovery from incomplete spinal cord injury. J Neurotrauma. 2008 May;25(5):467-78. doi: 10.1089/neu.2007.0472.
PubMed 18419251Yozbatiran N, Berliner J, O'Malley MK, Pehlivan AU, Kadivar Z, Boake C, Francisco GE. Robotic training and clinical assessment of upper extremity movements after spinal cord injury: a single case report. J Rehabil Med. 2012 Feb;44(2):186-8. doi: 10.2340/16501977-0924.
PubMed 22334347
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Monitoring, tDCS and Robotic Training in SCI
- ClinicalTrials.gov ID
- NCT06813287
- Acronym / sponsor ID
- BRC442
- Conditions
- Spinal Cord Injuries
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Kathleen FrielUniversity, hospital or other
- Study start
- 1 Nov 2012 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 27 Jun 2018 (actual)
- First posted
- 6 Feb 2025 (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.
To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with upper-limb robotic therapy (Study 2), as well as to characterize the neurophysiological (TMS) and brain signaling (EEG) profile of patients and specific muscles that respond to the combination of neuromodulation and robotic motor training.
Detailed description
Current training interventions for rehabilitating patients with SCI are designed to provide the greatest possible restoration of function in the shortest possible time. One of the major deficits in our current approach to applying therapy is that we have little ability to predict which patients are most likely to respond to therapy or which muscle groups are most amenable to improvement. Transcranial magnetic stimulation (TMS) is a noninvasive method to excite or inhibit neurons in the brain or the spinal cord. Numerous studies have been using this technique to map connections from the motor cortex via the spinal cord to peripheral muscles; and as a therapeutic tool to promote useful plasticity.
The significance of the present study lies in the potential of intensive upper limb motor training with a novel robotic device, in conjunction with transcranial direct current stimulation (tDCS) over the contralateral motor cortex, may enhance neural recovery and upper limb function in patients with tetraplegia.
The robotic training devices represent the most sophisticated interactive rehabilitation systems available on the current market; they are additionally appealing for their ability to quantify various aspects of movement, and they appear to be particularly powerful way to promote functional recovery. Furthermore, robotic devices can be used in collection of quantitative data from the patients, which can be interpreted to analyze their rate of progress. Rehabilitation robots are capable of providing important components of motor skill learning and muscle training: individually prescribed intensity, repetition, and performance feedback. Furthermore, they are a novel and reliable method of assessing voluntary motor control. Our center has extensive experience in the use of rehabilitation robotics in the assessment and training of voluntary motor control in SCI patients, as well as other neurological disorders. From the investigator's previous experience using robotic therapy in SCI patients they can predict that some patients (approximately 10%) will show direct benefits from the interactive robot training.
The use of neuromodulatory techniques (TMS, tDCS) has been used for the last 2 decades in neurorehabilitation with the aim of enhance motor recovery when paired with activity dependent plasticity (training). In this proposal the investigator's will be using a new tDCS device, StarStim® - a wireless multichannel device that allows EEG recording as well as real or sham tDCS stimulation.
The purpose of this study is: To explore the neurophysiological and electroencephalography (EEG) changes that one single session of tDCS and robotics has in the SCI population (Study 1); and to investigate upper limb motor recovery in chronic tetraplegia SCI patients, comparing two rehabilitation strategies: real or sham tDCS combined with upper-limb robotic therapy (Study 2), as well as to characterize the neurophysiological (TMS) and brain signaling (EEG) profile of patients and specific muscles that respond to the combination of neuromodulation and robotic motor training.
Study 1, Objective: To evaluate changes in cortical neurophysiological and biological brain signaling after a single session of tDCS. The TMS responses of the upper limb muscles with lack of voluntary motor control will be assessed prior and after 20 min of tDCS intervention. Additionally, the investigators will record EEG activity before, during and after the intervention.
Study 2, Objective: To explore the accumulative effects of 2 weeks of tDCS + Robotic training in cortical excitability and brain signaling. In addition, the investigators will investigate whether the intensive robotic training in conjunction with tDCS over the contralateral motor cortex area will enhance neural recovery and upper limb function in patients with tetraplegia.
The investigators will compare two different brain stimulation protocols to assess the enhancement of the motor performance of those muscles that lack motor control, comparing the effects of 2-weeks intensive hand-robotic training with real or sham tDCS.
The investigators hypothesize that the patients who undergo real tDCS in conjunction with prolonged intense robotic training will achieve greater improvements in motor function and sensation compared to their counterparts who are in the sham control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tDCS & EEG | Experimental | Diagnostic Test: Electroencephalography (EEG)20 minutes of real anodal tDCS of cortical neurophysiology and EEG responses in chronic spinal cord injury patients. |
| Sham tDCS | Sham comparator | Device: Upper extremity robot2 weeks (5x per week) of upper limb robotic training in conjunction with sham tDCS. |
| Active tDCS | Experimental | Device: Upper extremity robot2 weeks (5x per week) of upper limb robotic training in conjunction with active tDCS. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Level of injury C5 to T1
- Chronic SCI > 6 months
- Tetraplegic with some degree of motor dysfunction in the upper limb
- Motor Incomplete/Complete
- Medically stable
Key exclusion criteria (14 listed)
- < 6 month after injury
- History of head trauma and/or cognitive deficit
- History of stroke, seizures or other intracranial disease
- Medically unstable
- Concomitant neurological disorder
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 |
|---|---|---|
| Electroencephalography (EEG)Recording of electrical activity in the brain | Diagnostic test | tDCS & EEG |
| Upper extremity robotUsed for training and objective assessment (kinematics) | Device | Active tDCS, Sham tDCS |
Primary outcome
Motor Threshold
Time frame: Change in motor threshold from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.
The necessary stimulator output to evoke a response in the target muscle
Action Research Arm Test
Time frame: Baseline, immediately after intervention.
Assessment of upper extremity motor improvements
Amplitude of Response
Time frame: Change in amplitude from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.
The size of the wave form (response) generated during motor threshold determination.
9 secondary outcomes
Transcranial magnetic stimulation mapping
Time frame: Baseline, immediately after intervention, and 1 month follow up
Electroencephalography (EEG) Recording
Time frame: Baseline, immediately after intervention, and 1 month follow up
Muscle Strength Evaluation
Time frame: Baseline, immediately after intervention, and 1 month follow up
Upper Extremity Motor Score (UEMS)
Time frame: Baseline, immediately after intervention
Spinal Cord Independence Measure (SCIM III)
Time frame: Baseline, immediately after intervention
Visual Analogue Scale
Time frame: Baseline, immediately after intervention
Quadriplegia Index of Function (QIF)
Time frame: Baseline, immediately after intervention
Jebsen-Taylor Hand Function Test
Time frame: Baseline, immediately after intervention
Motor Evoked Potential Facilitation
Time frame: Baseline, immediately after intervention, and 1 month follow up
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 6 Feb 2025.
- Background: PubMed 16629638Barbeau H, Nadeau S, Garneau C. Physical determinants, emerging concepts, and training approaches in gait of individuals with spinal cord injury. J Neurotrauma. 2006 Mar-Apr;23(3-4):571-85. doi: 10.1089/neu.2006.23.571.
- Background: PubMed 17543768Behrman AL, Harkema SJ. Physical rehabilitation as an agent for recovery after spinal cord injury. Phys Med Rehabil Clin N Am. 2007 May;18(2):183-202, v. doi: 10.1016/j.pmr.2007.02.002.
- Background: PubMed 19243615Krebs HI, Volpe B, Hogan N. A working model of stroke recovery from rehabilitation robotics practitioners. J Neuroeng Rehabil. 2009 Feb 25;6:6. doi: 10.1186/1743-0003-6-6.
- Background: PubMed 19543659Spooren AI, Janssen-Potten YJ, Kerckhofs E, Seelen HA. Outcome of motor training programmes on arm and hand functioning in patients with cervical spinal cord injury according to different levels of the ICF: a systematic review. J Rehabil Med. 2009 Jun;41(7):497-505. doi: 10.2340/16501977-0387.
- Background: PubMed 18419251Wirth B, Van Hedel HJ, Curt A. Changes in corticospinal function and ankle motor control during recovery from incomplete spinal cord injury. J Neurotrauma. 2008 May;25(5):467-78. doi: 10.1089/neu.2007.0472.
- Background: PubMed 22334347Yozbatiran N, Berliner J, O'Malley MK, Pehlivan AU, Kadivar Z, Boake C, Francisco GE. Robotic training and clinical assessment of upper extremity movements after spinal cord injury: a single case report. J Rehabil Med. 2012 Feb;44(2):186-8. doi: 10.2340/16501977-0924.
- Individual participant dataSharing planned: No. 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.
Mar Cortes, MD principal investigator
Mt Sinai School of Medicine
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 Electroencephalography (EEG) and Upper extremity robot in people with Spinal Cord Injuries, run by Kathleen Friel 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 5 inclusion and 14 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 6 Feb 2025. 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 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?
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?
Motor Threshold (time frame: Change in motor threshold from baseline to immediately post-intervention. This measure will also be repeated at a 1 month follow up evaluation.). The study lists 3 primary outcomes in all. 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 NCT06813287, which also lists 6 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 6 Feb 2025.