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

NCT02711319 | Completed Phase 3

• 1 other identifier: PI10/00442
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Functional Improvement

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

Study Arms (2)

active (real) rTMS (ACTIVE GROUP)

ACTIVE COMPARATOR

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.

Device: rTMS

sham rTMS (SHAM GROUP)

SHAM COMPARATOR

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).

Device: sham rTMS

Interventions

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

Also known as: active rTMS, active group, real rTMS

active (real) rTMS (ACTIVE GROUP)

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).

Also known as: sham group, placebo group

sham rTMS (SHAM GROUP)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institut Guttmann: lead
• Instituto de Salud Carlos III: collaborator

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 9, 2016
• First Posted: March 17, 2016
• Study Start: December 1, 2010
• Primary Completion: June 1, 2015
• Study Completion: August 1, 2015
• Last Updated: March 17, 2016

Record last verified: 2016-02