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

NCT02711319 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2016-03-17

No results posted yet for this study

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.

Conditions

  • Functional Improvement

Interventions

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

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).

Sponsors & Collaborators

  • Instituto de Salud Carlos III

    collaborator OTHER_GOV

  • Institut Guttmann

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2015-06-30
Completion
2015-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02711319 on ClinicalTrials.gov