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

ISRCTN	ISRCTN27103516
DOI	https://doi.org/10.1186/ISRCTN27103516
Secondary identifying numbers	N0234108360

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

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

Study information

Study design	Randomised double-blind placebo controlled crossover group open trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effect of methylphenidate on neural mechanisms underlying attention deficit after closed head injury
Study objectives	Do 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) studied	Attention deficit after closed head injury
Intervention	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.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methylphenidate
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/05/2003
Completion date	30/04/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20
Key inclusion criteria	Closed head injured patients
Key exclusion criteria	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
Date of first enrolment	01/05/2003
Date of final enrolment	30/04/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Burden Neurological Institute

Bristol
BS16 1JB
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.doh.gov.uk

Funders

Funder type

Charity

The Big Lottery Fund (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

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