Therapy to Improve Reaching Movement in Upper Limb

NCT ID: NCT03508037

Last Updated: 2018-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-12
• Study Completion Date: 2019-05-31

Brief Summary

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.

Conditions

Stroke; Impairment Upper Limb

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental group

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

Group Type: EXPERIMENTAL

Neuromodulation electroencephalographic signals and functional electrical stimulation based

Intervention Type: OTHER

First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV). Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).

Control group

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.

Group Type: ACTIVE_COMPARATOR

Neuromodulation electroencephalographic signals and functional electrical stimulation based

Intervention Type: OTHER

First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV). Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).

Interventions

Neuromodulation electroencephalographic signals and functional electrical stimulation based

First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV). Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).

Intervention Type: OTHER

Other Intervention Names

Neuromodulation

Eligibility Criteria

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

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

Sponsors

Centro de Referencia Estatal de Atención Al Daño Cerebral

OTHER

Sponsor Role: collaborator

Centro Universitario La Salle

OTHER

Sponsor Role: collaborator

Cajal Institute of the Spanish National Research Council

OTHER

Sponsor Role: lead

Responsible Party

Oscar Herrero Gimenez

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jose Luis Pons

Role: PRINCIPAL_INVESTIGATOR

Centro Superior de Investigaciones Científicas (CSIC)

Locations

Centro de Referencia Estatal de Atención al Daño Cerebral (CEADAC)

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Oscar Herrero

Role: CONTACT

oscar.herrero@cajal.csic.es

+ 34 645 16 31 66

Facility Contacts

Carlos Gonzalez

Role: primary

cgonzaalted@imserso.es

+34 696993123

Other Identifiers

CSEULS-PI-106/2016

Identifier Type: -

Identifier Source: org_study_id