Combined Robotic Training and tDCS in Chronic SCI

NCT03555838 | Unknown Phase 3 FDA Device

• 1 other identifier: BRC549
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Tetraplegia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Upper Extremity Motor Score

  Baseline, immediately post-intervention, and 1 month follow up

• Spinal Cord Independence Measure (SCIM III)

  Baseline, immediately post-intervention, and 1 month follow up

• Modified Ashworth Scale

  Baseline, immediately post-intervention, and 1 month follow up

• Nine Hole Peg Test

  Baseline, immediately post-intervention, and 1 month follow up

• Questionnaire of von Korff et al Grading the Severity of Chronic Pain

  Baseline, immediately post-intervention, and 1 month follow up

Study Arms (2)

Active tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

transcranial direct current stimulation OTHER

Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head.

Active tDCS

sham transcranial direct current stimulation OTHER

an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes.

Sham tDCS

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Burke Medical Research Institute

White Plains, New York, 10605, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Quadriplegia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All participants, raters, and experimenters will be blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: June 14, 2018
• Study Start: May 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: December 1, 2023
• Last Updated: March 2, 2022

Record last verified: 2022-02

Locations

US (1)