Caffeine, catecholamines and tremor

ISRCTN	ISRCTN54747943
DOI	https://doi.org/10.1186/ISRCTN54747943
Secondary identifying numbers	N0265122314

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 27/01/2015

Recruitment status: No longer recruiting
Overall study status: Completed
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

Prof M J Kendall
Scientific

Clinical Investigation Unit
University of Birmingham
Birmingham
B15 2TT
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Caffeine, catecholamines and tremor
Study objectives	The study has 2 aims: 1. To investigate the short term effects of caffeine on tremor and relate them to other beta-2 mediated changes. 2. To investigate the nature of the tremor response to beta-2 agonists. The generally accepted explanation for the tremorogenic effect of these drugs is that the twitch properties of the muscles are changed. The twitch becomes faster and the tetanic filsion frequency increases. As a consequence, for any likely rate of motor neuron firing the response of the muscle becomes more pulsatile. We will record tremor with a new isometric apparatus which allows this conclusion to be directly tested. Any component of the tremor which alternatively results from central activation can be distinguished by this new technique. For information: Whairad HJ, Birmingham AT, MacDonald IA, Inch PJ, Mead JL. The influence of fasting and caffeine intake on finger tremor. European Journal of Clinical Pharmacology 1985:29;37-43. See http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=4054205&query_hl=7&itool=pubmed_docsum
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Nervous System Diseases: Tremor
Intervention	Suitable volunteers will be seen prior to entry to the study. A full history and examination will be performed, including details of smoking, alcohol and caffeine intake. They will be given a written information sheet and a full explanation of the nature and purpose of the study. They will be asked to sign a consent form if they wish to take part. The study will consist of five visits to the clinical investigation unit each separated by at least 72 hours from the preceding and following study day. Prior to each study day the volunteer will abstain from caffeine containing foods and beverage for 48 hours and will not drink alcohol for the 24 hours preceding the investigation. Each visit will follow a standard protocol. The volunteer will attend and a cannula will be inserted into each ante-cubital fossa. Baseline tremor and associated cutaneous electromyography (EMG), blood pressure and pulse rate will be measured using standard non-invasive techniques. Additionally a blood sample (to analyse for potassium, glucose and insulin concentrations) will be taker) prior to the volunteer receiving an oral dose of caffeine at 7mg/kg or placebo. 45 minutes after administration the volunteers' tremor, blood pressure and pulse rate will be measured and a blood sample taken. An infusion of the terbutaline (at either 2 or 7 µg/kg/minute or placebo (saline) at 35 ml/hour) intravenously infrised at the prescribed rate. The volunteers' tremor, blood pressure and pulse rate will be measured and a blood sample taken four more times at 15-minute intervals. The volunteer will then depart. This basic procedure will be repeated for each visit. The volunteer will be required to attend five times in order to receive the following combinations: An oral dose of caffeine at 7mg/kg with placebo infusion. A placebo tablet with a terbutaline infusion of 2 µg/kg/hr set up and run for 45 minutes. A placebo tablet with a terbutaline infusion of 7 µg/kg/hr set up and run for 45 minutes. Caffeine at 7mg/kg plus Terbutaline infusion at 2 µg/kg/hr set up and run for 45 minutes. Caffeine at 7mg/kg plus Terbutaline infusion at 7 µg/kg/hr set up and run for 45 minutes. These different treatments will be performed in a randomized order.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Caffeine, terbutaline
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	16/03/2003
Completion date	16/03/2008

Eligibility

Participant type(s)	Healthy volunteer
Age group	Adult
Lower age limit	18 Years
Upper age limit	39 Years
Sex	Both
Target number of participants	8
Key inclusion criteria	8 healthy volunteers aged 18-39 years of either sex will be recruited. They will each act as their own control. They will be taking no other medication (with the exception of the oral contraceptive pill).
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	16/03/2003
Date of final enrolment	16/03/2008

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University of Birmingham

Birmingham
B15 2TT
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website	http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Hospital/treatment centre

University Hospital Birmingham NHS Trust (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