NCT02562001

Association Between tDCS and Lokomat Training in Patients With Incomplete Spinal Cord Injury

Completed NA Last updated 8 June 2021

What this trial tests

NA trial testing Outpatient active group in Spinal Cord Injuries in 42 participants. Completed in 5 May 2018.

Timeline

6 May 2015

Primary endpoint
5 May 2018

5 May 2018

Quick facts

Lead sponsor	University of Sao Paulo General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	42
Start date	6 May 2015
Primary completion	5 May 2018
Estimated completion	5 May 2018
Sites	1 location across Brazil

Drugs / interventions tested

• Outpatient active group
• Outpatient placebo group
• Inpatient active group
• Inpatient placebo group

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →

Sponsor

University of Sao Paulo General Hospital

Who can join

Adults 18 to 65, any sex, with Spinal Cord Injuries. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The spinal cord injury is identified as the major cause of permanent disability worldwide, with the loss of ability to walk being the largest and most devastating of them for these patients. Our goal is to analyze the effects of electrical transcranial direct-current stimulation (tDCS) combined with gait training with partial body weight support aided by robotic device (Lokomat, Hocoma) in the gait of patients with incomplete spinal cord injury (SCI). In this stratified randomized double-blind study, the participants will be randomly allocated into one of both groups, outpatients (GA) or inpatients (GI), and will receive active or placebo tDCS followed by gait training with Lokomat (GA: 3 sessions/week x 10 weeks = 30 sessions; GI: 5 sessions/week x 6 weeks = 30 sessions). The functional assessments (through clinical and functional scales, assess gait, muscle strength, spasticity, balance and pain) and neurophysiological (cortical excitability measured by transcranial magnetic stimulation, electroencephalography and functional near-infrared spectroscopy) will be held before and after the training period. The functional assessments will be also held after 15 sessions (intermediate) and after 3 months follow up. The expected result is that patients that received the active tDCS presents an improvement over the ground gait after the Lokomat training period significantly greater than the placebo group, with relations between neurophysiologic, kinematics and functional measurements.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Transcranial direct current stimulation combined with robotic training in incomplete spinal cord injury: a randomized, sham-controlled clinical trial.
   Simis M, Fregni F, Battistella LR. · · 2021 · cited 16× · PMID 34580282 · DOI 10.1038/s41394-021-00448-9
2. Combining Therapeutic Strategies to Treat the Injured Spinal Cord: A Translational Perspective.
   Sherman BC, Schmidt Read M, Hoh DJ, Guest JD, et al · · 2025 · cited 2× · PMID 40929022 · DOI 10.1177/08977151251371710