Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury (SLT)

November 13, 2015 updated by: Edelle Field-Fote, University of Miami

The study investigates the effect of using transcranial direct current stimulation (tDCS) and skilled stepping training versus skilled stepping training with sham-tDCS in improving ankle and leg motor control in persons with ambulatory persons with spinal cord injury.

Hypotheses H1: Participants will display greater improvement in stepping function following tDCS combined with training compared to sham-tDCS and training.

H2: Participants will display greater gains in cortical excitability, as evidenced by lower cortico-motor threshold (MT) associated with the TA muscles following tDCS and training compared to following sham stimulation and training.

H3: Participants in the tDCS+training group will show greater increases walking speed in a timed 10 meter walking trial.

H4: Participants in the tDCS+training group will show be able to perform a greater number of toe-taps test.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

An estimated 265,000 individuals live with the consequences of SCI in the United States alone. Individuals with motor incomplete spinal cord injury (MISCI) commonly experience loss or impairment of lower extremity function. There are a limited number of options for restoration of walking function in individuals with motor-incomplete spinal cord injury (MISCI) who exhibit some ability to stand and walk but may be impeded by impaired voluntary control of the lower limb particularly, the ankle.

In persons with spinal cord injury, walking function is often limited by poor ability to lift and advance the legs. Lower extremity orthotic devices may be employed to stabilize the ankle joint and provide toe clearance during walking. However, these devices are cumbersome, and may be aesthetically unappealing.

Newer evidence indicates that non-invasive approaches to brain stimulation may provide a way to improve voluntary control of the legs and ankles in persons with neurologic disorders.

Purpose of this research study:

The overall goal of this study is to develop functional rehabilitation strategies that facilitate optimal restoration of leg and ankle motor control in individuals with MISCI. Individuals with MISCI exhibit some motor function below the level of lesion and include American Spinal Injury Association Impairment Scale (AIS) classifications AIS C and AIS D. We propose to test non-invasive cortical stimulation in combination with lower-extremity functional motor training for its ability to assist in improving fine motor control of the lower limbs in individuals with MISCI.

Studies have shown that non-invasive transcranial direct current stimulation (tDCS) can increase activity in specific cortical areas associated with motor learning, and therefore improve on the cortical and functional effects associated with motor practice training in individuals with SCI. If brain stimulation in combination with motor training is found to enhance improvements in control more effectively than motor training alone, this would provide a basis for further examining stimulation combined with lower limb joint therapy in individuals with spinal cord injury.

Objectives: To Assess improvements in lower extremity motor control that are associated with bilateral tDCS and functional motor training or sham tDCS and functional motor training in individuals with motor incomplete spinal cord injury.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • The Miami Project to Cure Paralysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Motor incomplete Spinal cord injured subjects.
  • Ability to walk 10 m with or without walking aides.
  • Ability to Dorsiflex (Move foot up) at least 5 degrees from sitting.

Exclusion Criteria:

  • Seizures
  • Cognitive function impairment
  • Brain surgery or intracranial metal implants.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS and skilled training
tDCS and skilled leg training. Transcranial direct current stimulation + step training TDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Device: Transcranial direct current stimulation + step training
Direct current stimulation of motor cortex with low stimulation intensity
Behavioral: Sham transcranial direct current stimulation + step training
Stepping over specified soft foam obstacles
Other Names:
  • Stepping training
Sham Comparator: Sham tDCS and skilled leg training
Sham (Non active) tDCS and skilled leg training. 'Sham transcranial direct current stimulation + step training Sham tDCS will be delivered to the motor cortical area in conjunction with skilled locomotor training
Behavioral: Sham transcranial direct current stimulation + step training
Stepping over specified soft foam obstacles
Other Names:
  • Stepping training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Midswing Ankle ROM
Time Frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Change From Baseline Active Motor Threshold
Time Frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline Scores of a 10 m Walk Test
Time Frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Change from baseline score of the time required to perform 10 m walking.
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Change From Baseline Score on Toe Tap Test
Time Frame: Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Measuring the Time required to perform toe taps
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Edelle C Field Fote, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

September 30, 2013

First Submitted That Met QC Criteria

October 9, 2013

First Posted (Estimate)

October 14, 2013

Study Record Updates

Last Update Posted (Estimate)

November 16, 2015

Last Update Submitted That Met QC Criteria

November 13, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20110344

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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