Non-invasive Brain Stimulation for Gait Improvement in Patients With Spinal Cord Injury (SCI)

Non-invasive Brain Stimulation in SCI

to optimize the functional outcome in early phase of gait rehabilitation in subacute incomplete SCI patients using rTMS as an additional treatment to physical therapy (e.g. to gait training in Lokomat®). Using this add-on therapeutic strategy, we expected larger improvement of gait function than with physical therapy alone.

Study Overview

• Status: Completed
• Conditions: Functional Improvement
• Intervention / Treatment: Device: rTMS; Device: sham rTMS

Detailed Description

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive and painless procedure to modulate cortical excitability of motor areas and induce changes over the descending corticospinal output. This modulation may be useful to promote active recovery of motor function and to obtain functional benefit from gait rehabilitation. Through the use of repetitive high-frequency rTMS, improvement has been reported in motor and sensory functions measured by American Spinal Cord Injury Association (ASIA) Impairment Scale (AIS), and time to complete a peg-board task in four chronic incomplete cervical SCI patients.

Physical therapy aims to improve function of both undamaged and also, as far as possible, damaged neuronal structures. However, 'reorganization' of neuronal circuits is the target of specific training approaches. Therefore, the challenge is to guide CNS plasticity in order to optimize the functional outcome for a given individual. Hypothesized was that high-frequency rTMS coupled with gait training can improve motor recovery in the lower extremities and locomotion in incomplete SCI patients to a greater degree than sham stimulation.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

inclusion criteria:

1. had subacute motor incomplete SCI (AIS-C or D),
2. candidate for gait rehabilitation with Lokomat® after cervical or thoracic SCI;
3. stable medical treatment at least one week before and during the study;
4. without limitation of passive range of movement in joints
5. agreed to participate after signing a written informed consent form.

exclusion criteria:

1. unstable clinical state
2. severe spasticity (MAS>=3)
3. disagreed to sign consent form

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: active (real) rTMS (ACTIVE GROUP); The patients were randomly distributed in two study groups: real or sham rTMS group. For real rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes.	Device: rTMS; For real (active) rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes; Other Names: active group; active rTMS; real rTMS
Sham Comparator: sham rTMS (SHAM GROUP); For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2).	Device: sham rTMS; Sham Comparator: sham rTMS (SHAM GROUP) For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2).; Other Names: sham group; placebo group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)	Patients with or without orthesis were asked to walk at their fastest but most comfortable speed and step length and cadence assessed during the 10MWT (We added the number of steps taken in 10 m. Step length (meters)=distance (m) x 2 / number of stops (heel to heel of same foot). Cadence (steps/min.)=number of steps x 60 / time (seconds))	Change from Baseline 10MWT at 4 and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Ashworth Scale (MAS)	Tests resistance to passive movement about a joint with varying degrees of velocity at knees	Change from Baseline MAS at 4 weeks
--Total motor score from upper (UEMS) and lower extremities (LEMS)	Total motor score from upper (UEMS) (score 50points) and lower extremities (LEMS) (score 50points) obtained from the standardized AIS clinical exam (total score=100)	Change from Baseline 1UEMS and LEMS at 4 and 8 weeks
Walking Index for SCI (WISCI) II	The ranking of severity of gait is based on the severity of the impairment and not on functional independence in the environment.	Change from Baseline WISCI-II at 4 and 8 weeks

Collaborators and Investigators

• Sponsor: Institut Guttmann
• Collaborators: Instituto de Salud Carlos III

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: March 9, 2016
• First Submitted That Met QC Criteria: March 13, 2016
• First Posted (Estimate): March 17, 2016

Study Record Updates

• Last Update Posted (Estimate): March 17, 2016
• Last Update Submitted That Met QC Criteria: March 13, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: PI10/00442

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED