Examine whether treatment with methylphenidate facilitates work rehabilitation for persons with long-term pain and mental fatigue after traumatic brain injury.

Examine whether treatment with methylphenidate facilitates work rehabilitation for persons with long-term pain and mental fatigue after traumatic brain injury. - Methylphenidate: work rehabilitation of people with pain and mental fatigue after brain injury

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-002096-14-SE

Enrollment

Registered

2015-07-03

Start date

2015-08-28

Completion date

Unknown

Last updated

2025-02-03

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

Conditions

Long-term pain and mental fatigue after traumatic brain injury and work rehabilitation.

Interventions

Trade Name: Ritalin (methylphenidate) Product Name: Methylphenidate Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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.	—

Countries

Sweden

Contacts

Public ContactGoran Delic

Sahlgrenska University Hospital

goran.delic@vgregion.se+46313421000

Outcome results

None listed

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