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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT06813287
Study groupRoleWhat they receive
tDCS & EEGExperimental20 minutes of real anodal tDCS of cortical neurophysiology and EEG responses in chronic spinal cord injury patients.
Receives: Diagnostic Test: Electroencephalography (EEG)
Sham tDCSSham comparator2 weeks (5x per week) of upper limb robotic training in conjunction with sham tDCS.
Receives: Device: Upper extremity robot
Active tDCSExperimental2 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.

  1. 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.

  2. Action Research Arm Test

    Assessment of upper extremity motor improvements

    Measured: Baseline, immediately after intervention.

  3. 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)
  1. 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

  2. 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

  3. Muscle Strength Evaluation

    Maximum voluntary contraction of the studied upper extremity muscle

    Measured: Baseline, immediately after intervention, and 1 month follow up

  4. Upper Extremity Motor Score (UEMS)

    Measure of upper extremity strength

    Measured: Baseline, immediately after intervention

  5. Spinal Cord Independence Measure (SCIM III)

    Measure of functional independence in activities of daily living

    Measured: Baseline, immediately after intervention

  6. Visual Analogue Scale

    Used as a self-report of pain

    Measured: Baseline, immediately after intervention

  7. Quadriplegia Index of Function (QIF)

    Quality of life scale

    Measured: Baseline, immediately after intervention

  8. Jebsen-Taylor Hand Function Test

    Assessment of fine motor skills

    Measured: Baseline, immediately after intervention

  9. 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.

  1. First posted6 Feb 2025
  2. Study start1 Nov 2012
  3. Primary completion31 Dec 2014
  4. Study completion27 Jun 2018

Resources

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)
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 16629638
  • Behrman 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 17543768
  • Krebs 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 19243615
  • Spooren 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 19543659
  • Wirth 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 18419251
  • Yozbatiran 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

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.

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