Condition category
Mental and Behavioural Disorders
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
25/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dolores Polo

ORCID ID

Contact details

Burden Neurological Institute
North Bristol NHS Trust
Frenchay Hospital
Frenchay
Bristol
BS16 1JB
United Kingdom
+44 (0)117 918 6723
dolorespolo@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0234108360

Study information

Scientific title

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

Acronym

Study hypothesis

Do event-related potentials provide objective markers to monitor drug effects in ameliorating attention deficits after closed head injury?

Ethics approval

Not provided at time of registration

Study design

Randomised double-blind placebo controlled crossover group open trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Methylphenidate

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/05/2003

Overall trial end date

30/04/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Closed head injured patients

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20

Participant 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

Recruitment start date

01/05/2003

Recruitment end date

30/04/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Burden Neurological Institute
Bristol
BS16 1JB
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Charity

Funder name

The Big Lottery Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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