Completed

NCT Number: NCT02711319

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

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.

Completed

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Key information

Conditions

Functional Improvement

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

rTMS

Device

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 rTMS, active group, real rTMS

sham rTMS

Device

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

Primary outcomes

ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)

Time frame: 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 outcomes

Modified Ashworth Scale (MAS)

Time frame: Change from Baseline MAS at 4 weeks

Tests resistance to passive movement about a joint with varying degrees of velocity at knees
--Total motor score from upper (UEMS) and lower extremities (LEMS)

Time frame: 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)
Walking Index for SCI (WISCI) II

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Institut Guttmann

Other

Collaborators

Instituto de Salud Carlos III

Registry information

Official study title

Non-invasive Brain Stimulation in SCI

Acronym: SCI

Important dates

Study start: 2010
Primary completion: 2015
Study completion: 2015
First posted: Mar 17, 2016
Registry last updated: Mar 17, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.