Effect of trans-spinal direct current stimulation and robotic support on the neural motor pathways in healthy and SCI subjects.

Effect of trans-spinal direct current stimulation and robotic support on the neural motor pathways in healthy and SCI subjects. - Effect of tsDCS and robotic support on the neural motor pathways

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45243

Enrollment

100

Registered

2014-12-18

Start date

2015-01-10

Completion date

Unknown

Last updated

2024-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

"Spinal Cord Injury" and "Paraplegia"

Interventions

For each experiment in this study, subjects will receive either tsDCS or robotic therapy as an intervention. Possible is also a combination of both techniques. tsDCS is applied to the lumbar spinal

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria for the healthy subjects are: at least 18 years old good vision (on 2 m distance) ;The inclusion criteria for chronic spinal cord injured subjects are: age > 18 years good vision (on 2 m distance) chronic stage: time since SCI > 12 months clear walking impairment but able to walk independently (with support) (WISCI > 1 and SCIM > 30) motor incomplete spinal cord injury (ASIA C or ASIA D) a stable medical condition Injury situated superior to the T9 vertebra

Exclusion criteria

Exclusion criteria: history of skin diseases that could result in irritation of the skin underneath the electrodes history of epilepsy or a known case of epilepsy in a first degree relative metallic implants in the body, unrelated to the spinal cord injury, in proximity to the stimulation electrodes metallic implants in the body, related to the spinal cord injury, below vertebrae T6 presence of cardiac pacemakers, cochlear implant or implanted brain electrodes use of any illegal drugs in the last year (possibility of) pregnancy current orthopedic problems other neurological disorders chronic joint pain history of cardiac conditions that interfere with physical load history of severe depression Stable use of anti-spasticity medication

Design outcomes

Primary

Measure	Time frame
Since this protocol does not describe a single experiment but a framework according to which a set of studies and experiments can be designed, there are many possible main outcome parameters which depend on the measurement techniques that will be employed. These may or may not all be part of a single study. The measurements that can be conducted before, during and after the main interventions are the assessments of: * H-Reflex * Somatosensory Evoked Potentials (SSEPs) * Motor Evoked Potentials (MEPs) * Walking Characteristics	—

Measure

Time frame

Since this protocol does not describe a single experiment but a framework according to which a set of studies and experiments can be designed, there are many possible main outcome parameters which depend on the measurement techniques that will be employed. These may or may not all be part of a single study. The measurements that can be conducted before, during and after the main interventions are the assessments of: * H-Reflex * Somatosensory Evoked Potentials (SSEPs) * Motor Evoked Potentials (MEPs) * Walking Characteristics

—

Secondary

Measure	Time frame
* Subject physical or mental discomfort during application of both interventions * Subject specific parameters that influence the effects of (the combination of) tsDCS and robotic gait training	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)