The effects of Modafinil on functional magnetic resonance imaging (fMRI) brain activation and functional performance during visual stimulation and visually guided tracking manoeuvres after sleep deprivation
| ISRCTN | ISRCTN37562266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN37562266 |
| Protocol serial number | C03.056 |
| Sponsor | Oxford Radcliffe Hospitals NHS Trust (UK) |
| Funder | Cephalon UK Ltd (UK) (ref: Davies2004/unrestricted grant) |
- Submission date
- 24/02/2005
- Registration date
- 13/04/2005
- Last edited
- 16/09/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Nervous System Diseases
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 Robert J.O Davies
Scientific
Scientific
Consultant in Respiratory Medicine
Oxford Centre for Respiratory Medicine
Churchill Hospital
Headington
Oxford
OX3 7LJ
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study acronym | Modafinil Study |
| Study objectives | Therefore we wish to examine brain activity and performance during hand/eye tracking manoeuvres, (as quantified by fMRI and our tracking tasks), in normal subjects before and after total sleep deprivation following treatment with Modafinil or placebo. We will compare whether the Modafinil has reversed the effects of the sleep deprivation, compared to placebo |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | N/A |
| Intervention | Please note that as of 16/09/09 the status of this trial has been changed to "Stopped" due to relocation of primary investigator (PI) and lack of funding. Each subject will be scanned 3 times, the first as a baseline, after normal sleep, and then twice after sleep deprivation, following treatment with Modafinil or placebo, in random order. Within each scanning session the subject will perform a series of hand/eye tracking tests of varying difficulty in random order, and a global visual stimulation test. Following the scans objective sleepiness will be quantified from the OSLER test of subjective sleepiness and steering ability will be quantified from the Oxford Steering Simulator. Subjects will be pre-trained to stable performance on the tracking task prior to fMRI scanning. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Modafinil |
| Primary outcome measure(s) |
The primary endpoint of the trial is the difference in activation of the occipital visual cortex area responsible motion detection (V5/MT) during global visual stimulation after Modafinil and placebo |
| Key secondary outcome measure(s) |
Sleep latency (measured by the OSLER test), driving simulator performance and tracking error will be secondary endpoints |
| Completion date | 30/06/2006 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | All |
| Target sample size at registration | 30 |
| Key inclusion criteria | 30 Healthy volunteers between the ages of 18-65 |
| Key exclusion criteria | Previous neurological disease |
| Date of first enrolment | 01/08/2004 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Consultant in Respiratory Medicine
Oxford
OX3 7LJ
United Kingdom
OX3 7LJ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
