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

NCT ID: NCT02711319

Last Updated: 2016-03-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-08-31

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.

Conditions

Functional Improvement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

active (real) rTMS (ACTIVE GROUP)

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.

Group Type: ACTIVE_COMPARATOR

rTMS

Intervention Type: 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

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).

Group Type: SHAM_COMPARATOR

sham rTMS

Intervention Type: 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).

Interventions

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

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

active rTMS; active group; real rTMS; sham group; placebo group

Eligibility Criteria

Inclusion Criteria

1. had subacute motor incomplete SCI (AIS-C or D),

2. candidate for gait rehabilitation with Lokomat® after cervical or thoracic SCI;

3. stable medical treatment at least one week before and during the study;

4. without limitation of passive range of movement in joints

5. agreed to participate after signing a written informed consent form.

Exclusion Criteria

1. unstable clinical state

2. severe spasticity (MAS>=3)

3. disagreed to sign consent form

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Instituto de Salud Carlos III

OTHER_GOV

Sponsor Role: collaborator

Institut Guttmann

OTHER

Sponsor Role: lead

Responsible Party

Joan Vidal

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PI10/00442

Identifier Type: -

Identifier Source: org_study_id