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Neurofeedback in Patients With Frontal Brain Lesions

NCT02957695 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-02-09

No results posted yet for this study

Summary

In this randomized double-blind controlled study we would like to test the benefit of neurofeedback for the recovery of patients with frontal brain injury during an early stage of neurorehabilitation.

Conditions

  • Brain Lesion

Interventions

DEVICE

Placebo-Neurofeedback

The Intervention used for the control-group consists of a sham-neurofeedback, which is based on a previous eeg-recording and doesn't respond to the actual brain activity. The fact, that it is not a real neurofeedback, cannot be recognized by the patient nor the trainer because the eeg recording is not visible and the program reacts to muscle contractions (where feedback reactions would be expected) but not to brain activity.

DEVICE

Active-Neurofeedback

The neurofeedback-method used in our study is called "infra-low frequency neurofeedback Training", developed by S. and S. Othmer. NeuroAmpII® is the device and Cygnet® the corresponding Software used for this method, both are approved as an active medicinal device (CE-marked) in the European Union and in USA (www.eeginfo.com). The device and the Software are produced by the Company BEE Medic GmbH, Kirchberg, CH.

Sponsors & Collaborators

  • Rehab Basel

    collaborator OTHER

  • Swiss Tropical & Public Health Institute

    collaborator OTHER

  • PD Dr. med. Margret Hund-Georgiadis

    lead OTHER

Principal Investigators

  • Margret Hund-Georgiadis, MD, PD · REHAB Basel, Switzerland

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02957695 on ClinicalTrials.gov