Therapy to Improve Reaching Movement in Upper Limb

Spanish National Research Council (CSIC)

Status: Unknown

Conditions: Stroke; Impairment Upper Limb

Treatments: Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based

Study type: Interventional

Funder types: Other

Identifiers

NCT03508037

CSEULS-PI-106/2016

Details and patient eligibility

About

Strokes are caused by a bleed in the brain and can be life threatening. One common consequence is upper limb impairment. This causes stroke patients to be unable to use their arms and upper body to do simple tasks such as reaching or grasping. Currently, people with stroke undergo rehabilitation, which is usually done through a physical and occupational (daily living skills) therapies to improve their mobility (movement) with their upper limbs. However, this kind of treatment has limitations and often cannot help patients regain total mobility. There are alternative rehabilitation treatments that use new methods and technologies that may be able to help patients with stroke. Neuromodulaton therapies using brain-computer interfaces (BCI), which connects brain signals directly to a computer, have the potential to help patients. This type of therapy uses assistive devices such as electrical stimulation (electrical shocks or waves) and robots to help restore function to the areas affected by stroke. The aim of this study is to evaluate and the potential benefits that can be achieved by using assistive devices in rehabilitation sessions with stroke patients.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• With response to Transcranial Magnetic Stimulation (TMS)
• Cortical or sub-cortical stroke patients
• With a score in the range of 22-44 on Fugl-Meyer scale or 2-4 on the Motor Assessment Scale
• With visible cortical patterns registered by BCI
• Subjects that tolerate electrical stimulation and that present a motor response
• Subjects with cognitive ability to follow instructions and perform the indicated tasks

Exclusion criteria

• Subjects with neurological injury prior to stroke or more than two events
• Patients with implanted devices
• Patients with severe motor paralysis
• Patients with epilepsy
• Patient with vision or hearing impairment

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

16 participants in 2 patient groups

Experimental group

Experimental group

Description:

The subject receives the Functional Electrical Stimulation (FES) when he or she has the intention to move. It is obtained through electroencephalography.

Treatment:

Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based

Control group

Active Comparator group

Description:

The subject receives the Functional Electrical Stimulation (FES) after o before (0.5 seconds) when he or she has the intention to move. It is obtained through electroencephalography.

Treatment:

Other: Neuromodulation electroencephalographic signals and functional electrical stimulation based