Brain Monitoring, tDCS and Robotic Training in SCI

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 Overview

• Status: Completed
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Diagnostic test: Electroencephalography (EEG); Device: Upper extremity robot

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New York
    • White Plains, New York, United States, 10605
      • Burke Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• < 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: tDCS & EEG; 20 minutes of real anodal tDCS of cortical neurophysiology and EEG responses in chronic spinal cord injury patients.	Diagnostic test: Electroencephalography (EEG); Recording of electrical activity in the brain
Sham Comparator: Sham tDCS; 2 weeks (5x per week) of upper limb robotic training in conjunction with sham tDCS.	Device: Upper extremity robot; Used for training and objective assessment (kinematics)
Experimental: Active tDCS; 2 weeks (5x per week) of upper limb robotic training in conjunction with active tDCS.	Device: Upper extremity robot; Used for training and objective assessment (kinematics)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transcranial magnetic stimulation mapping	Method of determining a specific muscle's spatial representation in the cortex.	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.	Baseline, immediately after intervention, and 1 month follow up
Muscle Strength Evaluation	Maximum voluntary contraction of the studied upper extremity muscle	Baseline, immediately after intervention, and 1 month follow up
Upper Extremity Motor Score (UEMS)	Measure of upper extremity strength	Baseline, immediately after intervention
Spinal Cord Independence Measure (SCIM III)	Measure of functional independence in activities of daily living	Baseline, immediately after intervention
Visual Analogue Scale	Used as a self-report of pain	Baseline, immediately after intervention
Quadriplegia Index of Function (QIF)	Quality of life scale	Baseline, immediately after intervention
Jebsen-Taylor Hand Function Test	Assessment of fine motor skills	Baseline, immediately after intervention
Motor Evoked Potential Facilitation	Method of assessing a nerves response to an external stimuli (transcranial magnetic stimulation)	Baseline, immediately after intervention, and 1 month follow up

Collaborators and Investigators

• Sponsor: Kathleen Friel
• Investigators: Principal Investigator: Mar Cortes, MD, Mt Sinai School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2012
• Primary Completion (Actual): December 31, 2014
• Study Completion (Actual): June 27, 2018

Study Registration Dates

• First Submitted: May 17, 2018
• First Submitted That Met QC Criteria: February 3, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 3, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: BRC442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data available to other researchers at this time.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No