Non-invasive electrostimulation of the brain as a treatment of alertness deficits after traumatic brain injury.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00006084

Enrollment

Registered

2014-10-13

Start date

2013-06-28

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain injury Organic psychosyndrome S06.0 S06.9

Interventions

Group 1: The cerebral cortex of the proband is stimulated by means of alternating currents in a frequency range from 5 to 30 Hz, with amplitudes between 100–800 µA with a total stimulation time of 20

Eligibility

Sex/Gender

All

Age

18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

Measure	Time frame
Aim is the improvement of alertness. The achievement of this aim will be examined 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. 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“).	—

Measure

Time frame

Aim is the improvement of alertness. The achievement of this aim will be examined 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. 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“).

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Countries

Germany

Contacts

Public ContactAndreas Gonschorek

Berufsgenossenschaftliches Unfallkrankenhaus Hamburg

a.gonschorek@buk-hamburg.de040 7036-2756

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026