An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

Stroke Rehabilitation Clinical Trial

Official title:

An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02603718
• Other study ID #: 2014-3
• Status: Completed
• Phase: N/A
• Start date: March 2014
• Est. completion date: August 28, 2017

Study information

• Verified date: May 2018
• Source: Reuth Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the efficacy of a simple and easy to use tool that can extract relevant attention-related markers - Brain Engagement Index (BEI) from ongoing EEG. During standard rehabilitative physical therapy sessions.

Description:

This research aims at assessing and fine tuning the effectiveness of a unique tool for online guidance of neural rehabilitation. The tool monitors patient attention level and guides the therapist online regarding the effectiveness of the current exercise employed. It is well established that maintaining a high level of attention plays a major role in the clinical outcome in rehabilitation. The monitoring is achieved using a cheap and simple to use EEG system and a breakthrough signal processing algorithm. The feedback provides the caregiver and patient with online information regarding the effectiveness of attention recruited during a given exercise. Furthermore, the investigators are developing and fine-tuning a set of guidelines to attain optimal attention levels. These guide lines include : Choosing an appropriate goal/movement for each patient; Regulating the optimal degree of effort by changing the difficulty level of the exercise, changing the exercise or suggesting a short rest period; Integrating supportive exercises such as stretches, strengthening of stabilizers normalization of muscle tone, sensory stimulation etc. which may enhance the performance of the target goal/movement; Motivating patients to exert more effort; And taking advantage of the quality control aspect of the BEI index in-order to augment attention of both therapist and patient.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: August 28, 2017
• Est. primary completion date: August 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients after stroke willing

Exclusion Criteria:

Related Conditions & MeSH terms

• Stroke
• Stroke Rehabilitation

Intervention

Other:
• Rehabilitation treatment

Locations

Country	Name	City	State
Israel	Reuth Rehabilitation Hospital	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Reuth Rehabilitation Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical outcome on a -3 to +3 scale	video	Change in performance between pre & post treatment, will be assessed twice, in the feedback session and non-feedback session. Each participant will be assessed twice within two weeks from recruitment to the study.
Primary	Mean brain engagement index during treatment.	scale from zero to one, the time in which the measure excedes a predefined threshhold level during tretment	During the whole treatment session, each participant will be assessed twice within two weeks from recruitment to the study.
Primary	Session effectiveness index	Scale from 1 to 3, the average of effectiveness evaluations for all the treatments in each session was used as the session effectiveness index	Through treatment sessions, each participant will be assessed twice within two weeks from recruitment to the study.