on-invasive electrostimulation of the brain as a treatment of alertness deficits after traumatic brain injury.
- Conditions
- ConcussionBrain injuryOrganic psychosyndromeS06.0S06.9Intracranial injury, unspecified
- Registration Number
- DRKS00006084
- Lead Sponsor
- Deutsche Gesetzliche Unfallversicherung
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 30
Female and male patients suffering traumatic brain injury due to an accident, with evidence of a diffuse-axonal or substantial brain injury by means of mri detection. Inclusion into study as early as one month after the accident.
Age range of patients 18-60 years.
Patients with electrical implants or metallic artefacts in the cranial region (exception: dental metall implants), severe or severest organic psychosyndromes, history of seizures, severe visual or hearing deficits, other disorders that could influence the study results such as hemiparesis, neglect or treatment with highly potent neuroleptica.
Further the occurence of complaints succeeding the electrostimulation such as hydrocephalus, seizures oder other serious medical conditions with potential effect on cognitive-mnestic performance (e.g. depression, psychosis).
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Aim is the improvement of alertness.<br>The achievement of this aim will be examined <br>before and after the stimulation period by means of neuropsychological testing. Stimulation, training and acquisition of the psychometric data will take place every day in the morning and for each proband at the same time of day.<br>The acquired data will be analysed by means of standardized, computer-based diagnostic test procedures such as TAP (Test of Attentional Performance , ZIMMERMANN & FIMM, 2009, Version 2.2. test modules will be „alertness; „permanent alertness und „divided attention).<br><br><br><br><br>
- Secondary Outcome Measures
Name Time Method