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ISRCTN
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ISRCTN27103516
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ClinicalTrials.gov identifier
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Public title
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Effect of methylphenidate on neural mechanisms underlying attention deficit after closed head injury
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Scientific title
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Acronym
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N/A
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Serial number at source
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N0234108360
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Study hypothesis
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Do event-related potentials provide objective markers to monitor drug effects in ameliorating attention deficits after closed head injury?
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised double-blind placebo controlled crossover group open trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Attention deficit after closed head injury
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Participants - inclusion criteria
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Closed head injured patients
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Participants - exclusion criteria
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1. 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
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Anticipated start date
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01/05/2003
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Anticipated end date
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30/04/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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20
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Interventions
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Double-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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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The Big Lottery Fund (UK)
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Trial website
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Publications
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Contact name
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Dr
Dolores
Polo
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Address
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Burden Neurological Institute
North Bristol NHS Trust
Frenchay Hospital
Frenchay
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City/town
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Bristol
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Zip/Postcode
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BS16 1JB
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Country
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United Kingdom
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Tel
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+44 (0)117 918 6723
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Fax
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+44 (0)117 918 6721
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Email
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dolorespolo@hotmail.com
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Sponsor
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Record provided by the NHS Trusts Clinical Trials Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)207 307 2622
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Fax
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+44 (0)207 307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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12/09/2003
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Last edited
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17/11/2009
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Date ISRCTN assigned
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12/09/2003
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