Combined Robotic Training and tDCS in Chronic SCI

Improving Hand Function in Chronic SCI With Combined Robotic Training and tDCS

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Spinal Cord Injuries; Tetraplegia
• Intervention / Treatment: Other: transcranial direct current stimulation; Other: sham transcranial direct current stimulation

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
• Enrollment (Actual): 13
• Phase: Phase 3

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: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Box and Blocks Test	A timed functional test to determine gross manual dexterity	Baseline, immediately post-intervention, and 1 month follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Motor Score	Manual muscle test of arm muscles; Score range from 0= no movement to 5= normal movement.	Baseline, immediately post-intervention, and 1 month follow up
Spinal Cord Independence Measure (SCIM III)	Evaluates patient's ability to complete activities of daily living; 19 questions in 3 domains; Scored 0 (severely impaired) -100 (independent)	Baseline, immediately post-intervention, and 1 month follow up
Modified Ashworth Scale	Measures spasticity; Each muscle assessed is scored between 0-4, with 4 indicating rigid limbs or very severely affected.	Baseline, immediately post-intervention, and 1 month follow up
Nine Hole Peg Test	Timed measure of fine motor skills and dexterity	Baseline, immediately post-intervention, and 1 month follow up
Questionnaire of von Korff et al Grading the Severity of Chronic Pain	Self-evaluation of pain; 7 questions in total; 0= no pain, 100= severe pain	Baseline, immediately post-intervention, and 1 month follow up
Quadraplegia Index of Function- Short Form	Global function scale; 6 items dcored on a 5 point scale from 0 (dependent) to 4 (independent).	Baseline, immediately post-intervention, and 1 month follow up

Collaborators and Investigators

• Sponsor: Burke Medical Research Institute
• Collaborators: New York State Spinal Cord Injury Research Board (SCIRB)

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2017
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: May 15, 2018
• First Submitted That Met QC Criteria: June 1, 2018
• First Posted (ACTUAL): June 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: February 28, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Spinal Cord Injuries; Quadriplegia
• Other Study ID Numbers: BRC549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• 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: Yes
• product manufactured in and exported from the U.S.: Yes