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

NCT01962675 | Terminated Results

• 1 other identifier: 20110344
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury

Keywords

tDCS; motor training; SCI

Outcome Measures

Primary Outcomes (2)

• 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.

  Two times, 1) Baseline, and 2) Up to 1 hour after intervention.

• Change From Baseline Active Motor Threshold

  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 Outcomes (2)

• Change From Baseline Scores of a 10 m Walk Test

  Two times, 1) Baseline, and 2) Up to 1 hour after intervention.

• Change From Baseline Score on Toe Tap Test

  Two times, 1) Baseline, and 2) Up to 1 hour after intervention.

Study Arms (2)

tDCS and skilled training

EXPERIMENTAL

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; Behavioral: Sham transcranial direct current stimulation + step training

Sham tDCS and skilled leg training

SHAM COMPARATOR

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

Interventions

Transcranial direct current stimulation + step training DEVICE

Direct current stimulation of motor cortex with low stimulation intensity

tDCS and skilled training

Sham transcranial direct current stimulation + step training BEHAVIORAL

Stepping over specified soft foam obstacles

Also known as: Stepping training

Sham tDCS and skilled leg training; tDCS and skilled training

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Edelle Field-Fote
• Organization: Shepherd Center

edelle_field-fote@shepherd.org

404-603-4274

Study Officials

• Edelle C Field Fote, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2013
• First Posted: October 14, 2013
• Study Start: July 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: November 16, 2015
• Results First Posted: November 16, 2015

Record last verified: 2015-11

Locations

US (1)