Effect of methylphenidate on neural mechanisms underlying attention deficit after closed head injury

ISRCTN ISRCTN27103516
DOI https://doi.org/10.1186/ISRCTN27103516
Protocol serial number N0234108360
Sponsor Department of Health (UK)
Funder The Big Lottery Fund (UK)
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
25/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Dolores Polo
Scientific

Burden Neurological Institute
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1JB
United Kingdom

+44 (0)117 918 6723
dolorespolo@hotmail.com

Study information

Primary study designInterventional
Study designRandomised double-blind placebo controlled crossover group open trial
Secondary study designRandomised controlled trial
Scientific titleEffect of methylphenidate on neural mechanisms underlying attention deficit after closed head injury
Study objectivesDo event-related potentials provide objective markers to monitor drug effects in ameliorating attention deficits after closed head injury?
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAttention deficit after closed head injury
InterventionDouble-blind, placebo controlled, crossover design and open trials (pilot study).

The study is aimed to evaluate the effectiveness of a neurophysiological method, Event-related brain potentials (ERPs), for monitoring the action of methylphenidate in normalising attention deficits after closed head injury. The drug will be administered in a prospective, two-group, randomised, double-blind, placebo-controlled, crossover design. Forty subjects who sustained a closed head injury will be examined in three occasions: a drug-free baseline session and after a counterbalanced treatment of 6 weeks course each of methylphenidate and placebo (lactose). Treatments will be separated by 1 week of wash-out to minimise carryover effects of medication. Drugs will be given orally. The dose of methylphenidate/placebo will start at 20 mg/day and will increase until reaching clinical effectiveness, up to 60 mg/day. Each examination will consist in the recording of a set of ERPs associated with attention function, from the scalp. Traditional behavioural and neuropsychological measures of attention will be also obtained from each patient.
Intervention typeDrug
PhaseNot Specified
Drug / device / biological / vaccine name(s)Methylphenidate
Primary outcome measure(s)

Not provided at time of registration

Key secondary outcome measure(s)

Not provided at time of registration

Completion date30/04/2006

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration20
Key inclusion criteriaClosed head injured patients
Key exclusion criteria1. Current history of neurological and/or psychiatric disorders
2. History of movement disorders
3. Epilepsy
4. Current use of MAO inhibitors or coumarin anticoagulants
5. Drug abuse
6. Problems of galactose intolerance
7. The Lapp lactase deficiency or glusoce-galactose malabsorption
8. Severe hypertension
9. Cardiac arrhythmia
10. Angina pectoris
11. Hyperthyroidism
12. Glaucoma
13. Thyrotoxicosis
14. Pregnancy
15. Severe hand motor deficit
Date of first enrolment01/05/2003
Date of final enrolment30/04/2006

Locations

Countries of recruitment

  • United Kingdom
  • England

Study participating centre

Burden Neurological Institute
Bristol
BS16 1JB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Editorial Notes

25/05/2016: No publications found, verifying study status with principal investigator

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