Brain Monitoring, tDCS and Robotic Training in SCI

NCT06813287 | Completed Phase 2

• 1 other identifier: BRC442
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (3)

• Motor Threshold

  The necessary stimulator output to evoke a response in the target muscle

  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

  Baseline, immediately after intervention.

• Amplitude of Response

  The size of the wave form (response) generated during motor threshold determination.

  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

  Baseline, immediately after intervention, and 1 month follow up

• Electroencephalography (EEG) Recording

  Baseline, immediately after intervention, and 1 month follow up

• Muscle Strength Evaluation

  Baseline, immediately after intervention, and 1 month follow up

• Upper Extremity Motor Score (UEMS)

  Baseline, immediately after intervention

• Spinal Cord Independence Measure (SCIM III)

  Baseline, immediately after intervention

Study Arms (3)

tDCS & EEG

EXPERIMENTAL

20 minutes of real anodal tDCS of cortical neurophysiology and EEG responses in chronic spinal cord injury patients.

Diagnostic Test: Electroencephalography (EEG)

Sham tDCS

SHAM COMPARATOR

2 weeks (5x per week) of upper limb robotic training in conjunction with sham tDCS.

Device: Upper extremity robot

Active tDCS

EXPERIMENTAL

2 weeks (5x per week) of upper limb robotic training in conjunction with active tDCS.

Device: Upper extremity robot

Interventions

Electroencephalography (EEG) DIAGNOSTIC_TEST

Recording of electrical activity in the brain

tDCS & EEG

Upper extremity robot DEVICE

Used for training and objective assessment (kinematics)

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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)
• 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

Sponsors & Collaborators

• Kathleen Friel: lead

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

Related Publications (6)

• 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.

  PMID: 16629638 BACKGROUND

• 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.

  PMID: 17543768 BACKGROUND

• 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.

  PMID: 19243615 BACKGROUND

• 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.

  PMID: 19543659 BACKGROUND

• 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.

  PMID: 18419251 BACKGROUND

• 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.

  PMID: 22334347 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis

Study Officials

• Mar Cortes, MD

  Mt Sinai School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lab Director, Clinical Laboratory for Early Brain Injury Recovery

Study Record Dates

• First Submitted: May 17, 2018
• First Posted: February 6, 2025
• Study Start: November 1, 2012
• Primary Completion: December 31, 2014
• Study Completion: June 27, 2018
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)