The Effects of rTMS and tDCS Combined With Robotic Rehabilitation In Patients With Spinal Cord Injury

NCT06188130 | Unknown

• 1 other identifier: 10025144
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effect of rTMS and tDCS combined with robotic therapy on motor functional recovery and gait parameters

Conditions

Chronic Spinal Cord Disorder

Outcome Measures

Primary Outcomes (3)

• Lower extremity motor scores according to ASIA examination

  ASIA (American Spinal Injury Association) Classification System is used to assess and determine the neurological status of individuals with spinal cord injuries. This classification system consists of five different classes: ASIA A:There is complete loss of motor and sensory function. ASIA B:Sensation is present in the sacral region (S4-S5), but motor function loss persists. ASIA C:Motor function loss persists, but there is observable muscle contraction (muscle strength) in specific muscle groups. ASIA D:Motor function loss continues, but uncontrolled movements can be observed. ASIA E:Normal sensory and motor functions are present. The ASIA classification is a widely used system for evaluating the severity and effects of spinal cord injuries. This classification provides important guidance for the planning of treatment and rehabilitation processes.

  initial, 3th week 9th week changes

• Walking Index for SCI - II (WISCI-II)

  Physical limitation for walking secondary to impairment is defined at the person level and indicates the ability of a person to walk after spinal cord injury. The development of this assessment index required a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former. The ranking of severity is based on the severity of the impairment and not on functional independence in the environment.

  initial, 3th week 9th week changes

• 10 meter walking test

  The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance\[1\]. It can be employed to determine functional mobility and gait.

  initial, 3th week 9th week changes

Secondary Outcomes (2)

• Modified Ashworth Scale

  initial, 3th week 9th week changes

• Visual Analogue Scale

  initial, 3th week 9th week changes

Study Arms (4)

active rTMS

EXPERIMENTAL

Participants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for lower extremity just after each active TMS sessions

Other: active rTMS

sham rTMS

SHAM COMPARATOR

Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for lower extremity just after each sham TMS sessions

Other: sham rTMS

active tDCS

EXPERIMENTAL

Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for lower extremity just after each active tDCS sessions

Other: active tDCS

sham tDCS

SHAM COMPARATOR

Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions

Other: sham tDCS

Interventions

active rTMS OTHER

Participants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed dominant side abductor pollicis brevis (APB).The patient received robotic therapy for lower extremity just after each active TMS sessions.

active rTMS

sham rTMS OTHER

Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for lower extremity just after each sham TMS sessions.

sham rTMS

active tDCS OTHER

Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the Cz central (International 10/20 Electroencephalogram System) area, corresponding to the location of the dominant hemisphere lower extremity motor cortex and cathodal to the contralateral supraorbital region. The patient received robotic therapy for lower extremity just after each active tDCS sessions.

active tDCS

sham tDCS OTHER

Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for lower extremity just after each sham tDCS sessions

sham tDCS

Eligibility Criteria

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

You may qualify if:

• Having traumatic SCI
• Between 6 months and 2 years after SCI
• years old
• Signing an informed consent form showing his/her consent to participate in the study.
• Motor incomplete cervical or thoracic SCI
• Spasticity in the lower extremity ≤2 according to the Modified Ashworth Scale

You may not qualify if:

• History of epilepsy
• A cardiac pacemaker
• Pregnancy
• Neurological diseases other than SCI
• Metallic implant in brain or scalp (including cochlear implant)
• Previous brain surgery
• Orthopedic disease that prevents lower extremity movements
• Diagnosis of malignancy
• Receiving robotic /TMS/tDCS treatments in the last 6 months

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara Bilkent City Hospital Pyhsical Treatment and Rehabilitation Hospital

Ankara, Turkey (Türkiye)

Location

Study Officials

• Emre Adıgüzel

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Emre Adıgüzel, Associate professor, Ankara City Hospital Bilkent

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: January 3, 2024
• Study Start: January 15, 2021
• Primary Completion: December 30, 2023
• Study Completion: January 15, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)