NCT02711319|CompletedPhase 3
Non-invasive Brain Stimulation for Gait Improvement in Patients With Spinal Cord Injury
SCI
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SCI
Sponsor study identifier
interventional
31
0 countries
N/A
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2015
Actual (reported)Study Completion
August 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
June 2015
Actual (reported)August 2015
Actual (reported)March 9, 2016
Actual (reported)March 17, 2016
Actual (reported)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
Modified Ashworth Scale (MAS)
Change from Baseline MAS at 4 weeks
--Total motor score from upper (UEMS) and lower extremities (LEMS)
Change from Baseline 1UEMS and LEMS at 4 and 8 weeks
Walking Index for SCI (WISCI) II
Change from Baseline WISCI-II at 4 and 8 weeks
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.
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).
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
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).
31 participants (actual enrollment reported by the registry).
First Submitted
March 9, 2016
First Posted
March 17, 2016
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Repetitive Transcranial Magnetic Stimulation of the Posterior Parietal Cortex in Patients Suffering From Gilles de la Tourette Syndrome
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 2015
Actual (reported)Study Completion
August 2015
Actual (reported)Last Updated
March 17, 2016
Record last verified: 2016-02
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Source: ClinicalTrials.gov.
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