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

Primary Purpose

Spinal Cord Injury

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation + step training
Sham transcranial direct current stimulation + step training
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Cord Injury focused on measuring tDCS, motor training, SCI

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Miami Project to Cure Paralysis

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS and skilled training

Sham tDCS and skilled leg training

Arm Description

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

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

Outcomes

Primary Outcome Measures

Change From Baseline Midswing Ankle ROM
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Change From Baseline Active Motor Threshold
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area

Secondary Outcome Measures

Change From Baseline Scores of a 10 m Walk Test
Change from baseline score of the time required to perform 10 m walking.
Change From Baseline Score on Toe Tap Test
Measuring the Time required to perform toe taps

Full Information

First Posted
September 30, 2013
Last Updated
November 13, 2015
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT01962675
Brief Title
Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury
Acronym
SLT
Official Title
Skilled Motor Training and tDCS to Improve Leg Function After Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Terminated
Why Stopped
PI left study institution, declined to continue study at new institution
Study Start Date
July 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury
Keywords
tDCS, motor training, SCI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
tDCS and skilled training
Arm Type
Experimental
Arm Description
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
Arm Title
Sham tDCS and skilled leg training
Arm Type
Sham Comparator
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation + step training
Intervention Description
Direct current stimulation of motor cortex with low stimulation intensity
Intervention Type
Behavioral
Intervention Name(s)
Sham transcranial direct current stimulation + step training
Other Intervention Name(s)
Stepping training
Intervention Description
Stepping over specified soft foam obstacles
Primary Outcome Measure Information:
Title
Change From Baseline Midswing Ankle ROM
Description
Measuring Ankle range of motion (ROM) first at Baseline and then up to 1 hour after intervention at the Midswing phase during Gait.
Time Frame
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Title
Change From Baseline Active Motor Threshold
Description
Measuring Active motor threshold using single pulse transcranial magnetic stimulation (TMS) of Motor cortex M1 area
Time Frame
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Secondary Outcome Measure Information:
Title
Change From Baseline Scores of a 10 m Walk Test
Description
Change from baseline score of the time required to perform 10 m walking.
Time Frame
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.
Title
Change From Baseline Score on Toe Tap Test
Description
Measuring the Time required to perform toe taps
Time Frame
Two times, 1) Baseline, and 2) Up to 1 hour after intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edelle C Field Fote, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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

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