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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-000925-60-SE

Enrollment

Registered

2011-02-25

Start date

2011-10-18

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Mental fatigue after traumatic brain injury or whip-lash injury

Interventions

Trade Name: methylphenidate Product Name: Ritalin 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 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

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: 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.	—

Measure

Time frame

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.

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Countries

Sweden

Outcome results

None listed

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