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

Phase 3

Completed

• Conditions: Functional Improvement

• Registration Number: NCT02711319
• Lead Sponsor: Institut Guttmann

Brief Summary

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.

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 Timeline

• Study Start: 2010-12
• Primary Completion: 2015-06
• Study Completion: 2015-08
• Status Verified: 2016-02
• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-13
• Last Update Submitted: 2016-03-13
• Study First Posted: 2016-03-17
• Last Update Posted: 2016-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)	Change from Baseline 10MWT at 4 and 8 weeks	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))

Secondary Outcome Measures

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