An Applicative On-line EEG Tool for Enhancing Treatment Efficacy

• ClinicalTrials.gov Identifier: NCT02603718
• Recruitment Status: Completed
• First Posted: November 13, 2015
• Last Update Posted: September 13, 2019
• Sponsor: Reuth Rehabilitation Hospital
• Information provided by (Responsible Party): Reuth Rehabilitation Hospital

Tracking Information

• First Submitted Date: October 14, 2015
• First Posted Date: November 13, 2015
• Last Update Posted Date: September 13, 2019
• Actual Study Start Date: March 2014
• Actual Primary Completion Date: August 28, 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 10, 2015)

• Clinical outcome on a -3 to +3 scale [ Time Frame: 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. ]
  video
• Mean brain engagement index during treatment. [ Time Frame: During the whole treatment session, each participant will be assessed twice within two weeks from recruitment to the study. ]
  scale from zero to one, the time in which the measure excedes a predefined threshhold level during tretment
• Session effectiveness index [ Time Frame: Through treatment sessions, each participant will be assessed twice within two weeks from recruitment to the study. ]
  Scale from 1 to 3, the average of effectiveness evaluations for all the treatments in each session was used as the session effectiveness index

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
• Official Title: An Applicative On-line EEG Tool for Enhancing Treatment Efficacy
• Brief 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.
• Detailed 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Stroke Rehabilitation
• Intervention: Other: Rehabilitation treatment

Study Arms

• Experimental: Standard physical therapy treatment with feedback
  Standard physical therapy rehabilitation is administered to stroke patients. Attention level of the patient gathered with an EEG tool is measured, and provided to both therapist and patient on-line during one of the two treatments.
  Intervention: Other: Rehabilitation treatment
• Experimental: Standard physical therapy treatment without feedback
  Standard physical therapy rehabilitation is administered to stroke patients. Attention level of the patient gathered with an EEG tool is measured but feedback is not provided.
  Intervention: Other: Rehabilitation treatment

• Publications *: Bartur G, Joubran K, Peleg-Shani S, Vatine JJ, Shahaf G. An EEG Tool for Monitoring Patient Engagement during Stroke Rehabilitation: A Feasibility Study. Biomed Res Int. 2017;2017:9071568. doi: 10.1155/2017/9071568. Epub 2017 Sep 24.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 12, 2019): 37
• Original Estimated Enrollment (submitted: November 10, 2015): 80
• Actual Study Completion Date: August 28, 2017
• Actual Primary Completion Date: August 28, 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Patients after stroke willing

Exclusion Criteria:

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT02603718
• Other Study ID Numbers: 2014-3
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Reuth Rehabilitation Hospital
• Study Sponsor: Reuth Rehabilitation Hospital
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Reuth Rehabilitation Hospital
• Verification Date: May 2018