Non-invasive Brain Stimulation in SCI
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Functional Improvement
- Sponsor
- Institut Guttmann
- Enrollment
- 31
- Primary Endpoint
- ten-meters walking test (10MWT=Time in seconds to walk 10 meters.)
- Status
- Completed
- Last Updated
- 10 years ago
Overview
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.
Investigators
Joan Vidal
MD, PhD
Institut Guttmann
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
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
- --Total motor score from upper (UEMS) and lower extremities (LEMS)(Change from Baseline 1UEMS and LEMS at 4 and 8 weeks)
- Modified Ashworth Scale (MAS)(Change from Baseline MAS at 4 weeks)
- Walking Index for SCI (WISCI) II(Change from Baseline WISCI-II at 4 and 8 weeks)