Examine whether treatment with methylphenidate facilitates work rehabilitation for persons with long-term pain and mental fatigue after traumatic brain injury.
- Conditions
- ong-term pain and mental fatigue after traumatic brain injury and work rehabilitation.Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2015-002096-14-SE
- Lead Sponsor
- Sahlgrenska University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1. Subjects who suffer from mental fatigue and pain due to a head trauma >12 months earlier. The persons are attended to by the Department of Neurology, 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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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: The study will be conducted in order to investigate whether methylphenidate improves pain and mental fatigue to that degree that the traumatic brain injury victim can more easily perform work rehabilitation. ;Secondary Objective: Not applicable.;Primary end point(s): to investigate the therapeutic effects of methylphenidate as measured by the self assessment questionnaire (MFS), with focus on mental fatigue and recovery, as specified in Protocol, and work capacity after 6 and 12 months, respectively. ;Timepoint(s) of evaluation of this end point: Three, six and twelve months, respectively.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Results from the neuropsychological tests, with focus on tests measuring information processing speed, effects on health economy and work capacity as specified in Protocol.;Timepoint(s) of evaluation of this end point: Three, six and twelve months, respectively.