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Combined Robotic Training and tDCS in Chronic SCI

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ClinicalTrials.gov Identifier: NCT03555838
Recruitment Status : Recruiting
First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Collaborator:
New York State Spinal Cord Injury Research Board (SCIRB)
Information provided by (Responsible Party):
Burke Medical Research Institute

Brief 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. The investigators hypothesize that supplementary tDCS will augment the functional improvement from robot-training, in chronic SCI.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Tetraplegia Other: transcranial direct current stimulation Other: sham transcranial direct current stimulation Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: All participants, raters, and experimenters will be blinded to treatment allocation.
Primary Purpose: Treatment
Official Title: Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : July 2019

Arm Intervention/treatment
Experimental: Active tDCS
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.
Other: transcranial direct current stimulation
Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head.

Sham Comparator: Sham tDCS
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.
Other: sham transcranial direct current stimulation
an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Upper Extremity Motor Score [ Time Frame: Baseline, immediately post-intervention, and 1 month follow up ]
    Manual muscle test of arm muscles; Score range from 0= no movement to 5= normal movement.

  2. Spinal Cord Independence Measure (SCIM III) [ Time Frame: Baseline, immediately post-intervention, and 1 month follow up ]
    Evaluates patient's ability to complete activities of daily living; 19 questions in 3 domains; Scored 0 (severely impaired) -100 (independent)

  3. Modified Ashworth Scale [ Time Frame: Baseline, immediately post-intervention, and 1 month follow up ]
    Measures spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.

  4. Nine Hole Peg Test [ Time Frame: Baseline, immediately post-intervention, and 1 month follow up ]
    Timed measure of fine motor skills and dexterity

  5. Questionnaire of von Korff et al Grading the Severity of Chronic Pain [ Time Frame: Baseline, immediately post-intervention, and 1 month follow up ]
    Self-evaluation of pain; 7 questions in total; 0= no pain, 100= severe pain

  6. Quadraplegia Index of Function- Short Form [ Time Frame: Baseline, immediately post-intervention, and 1 month follow up ]
    Global function scale; 6 items dcored on a 5 point scale from 0 (dependent) to 4 (independent).



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03555838


Contacts
Contact: Mar Cortes, MD 9143683181 mac2083@med.cornell.edu
Contact: Zoe Tsagaris, MS 9145972153 kzt3001@med.cornell.edu

Locations
United States, New York
Burke Medical Research Institute Recruiting
White Plains, New York, United States, 10605
Contact: Kathleen Friel, PhD    914-368-3116    braininjuryclinic@med.cornell.edu   
Sponsors and Collaborators
Burke Medical Research Institute
New York State Spinal Cord Injury Research Board (SCIRB)

Responsible Party: Burke Medical Research Institute
ClinicalTrials.gov Identifier: NCT03555838     History of Changes
Other Study ID Numbers: BRC549
First Posted: June 14, 2018    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: There is no plan to make individual participant data available to other researchers at this time.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Spinal Cord Injuries
Quadriplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms