Effect of treatment with methylphenidate on mental fatigue (brain fatigue”) and pain on persons who have suffered a traumatic brain injury or whip lash injury – a pilot study.

Conditions: Mental fatigue after traumatic brain injury or whip-lash injury

Registration Number: EUCTR2011-000925-60-SE

Lead Sponsor: Kungälv Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 30

Inclusion Criteria

1. Subjects who suffer from mental fatigue and pain due to a head trauma or a whip-lash trauma >12 months earlier. The persons are attended to by the Department of Neurology, SU/S, the Kungälv´s Pain Centre or the Multidisciplinary Pain Center, SU/Ö, Sahlgrenska University Hospital, SU/S. 2. Age 20 – 65. 3. Glasgow Outcome Scale (extended), moderate disability (~5) or better recovery.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Significant co-morbidity. Persons, where pain is the main problem. Persons with pain of other genesis as well as pain prone persons or a high degree of somatisation. 2. Major depression (according to DSM IV) prior to the trauma. 3. Organic personality disorder or other organic CNS disorder. Women of child-bearing age who are not on contraceptives. Pregnant women, Alcohol or drug abuse.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Investigate the therapeutic effects of methylphenidate as measured by self assessment questionnaire, with focus on mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered traumatic brain injury or whip-lash injury.;Secondary Objective: Study effects of methylphenidate on objective neuropsychological tests with focus on information processing speed and attention in these same patients.;Primary end point(s): Primary endpoint is to investigate the therapeutic effects of methylphenidate as measured by the self assessment questionnaire, with focus on the mental fatigue, recovery and concentration capacity in patients with mental fatigue who suffered a head trauma or a whip-lash trauma.

Secondary Outcome Measures