Plain English Summary
Background and study aims
Neuropathic pain is a long-term condition that causes daily pain that cannot be relieved by normal painkillers. The aim of this study is to see if a particular form of brain stimulation called Transcranial Direct Current Stimulation (tDCS) can help reduce the level of pain in patients with this condition.
Who can participate?
Male and female patients aged between 18 and 85 who have previously taken part in a study using magnetic brain stimulation.
What does the study involve?
A small electric current is passed through the skull to affect the surface of the brain beneath. It does not require surgery and can be done by a compact and mobile device. Three treatments will be tested: active stimulation (anodal), reverse active stimulation (cathodal) and a placebo (dummy) stimulation. All patients will receive all three treatments over three different sessions in a random order. Each treatment session will last four weeks with a total of 12 weeks duration. We will test tDCS in these patients, who will include both responders and non-responders to the previous magnetic stimulation treatment, and compare their average pain scores before and after treatment.
What are the possible benefits and risks of participating?
The advantage, to those who respond to tDCS, is that it can be used at home and therefore reduces the number of hospital appointments needed, as well as the cost and inconvenience of travel to and from the hospital. There are very few risks and these are very minor, including temporary headache, minor skin irradiation and tiredness.
Where is the study run from?
The study is run from the Walton Centre NHS Foundation Trust (UK) and the Pain Research Institute in Liverpool, UK.
When is the study starting and how long is it expected to run for?
Recruitment started in September 2012. The study is expected to finish in May 2015.
Who is funding the study?
Royal College of Physicians and Surgeons of Glasgow, UK.
Who is the main contact?
Dr Francis ONeill
foneill@liv.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
UoL000869 RG030/12
Study information
Scientific title
Evaluation of a mobile transcranial direct current stimulation device in chronic pain: a randomised controlled trial
Acronym
Study hypothesis
It is hypothesised that in a group of chronic neuropathic pain patients, transcranial direct current stimulation to the contralateral motor cortex will improve levels of perceived pain as assessed on a numerical pain scale rating.
Ethics approval
NRES Committee East of England - Cambridge East, 17/07/2012, ref: 12/EE/0315
Study design
Randomised sham controlled double crossover trial
Primary study design
Interventional
Secondary study design
Randomised cross over trial
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Neuropathic pain
Intervention
Transcranial direct current stimulation delivered to the contralateral motor cortex. Two active stimulations and one sham stimulation will be given over three different treatment sessions in a randomised manner.
Active stimulations: anodal and cathodal 1.4 mA over 25 cm x 25 cm area for 20 min a day for 5 days each
Sham stimulation: current ramp for 30 seconds and then current off for the remaining 19.5 min
Intervention type
Device
Phase
Not Applicable
Drug names
Primary outcome measure
Change in mean pain score as measured on a 0-10 point pain scale rating at baseline, and for two weeks starting on the first day of each treatment
Secondary outcome measures
1. Change in health-related quality of life SF-36
2. Change in anxiety or depression (HADS)
3. Global impression of change (GIC)
Secondary outcomes are measured at baseline and at 1 month following each treatment. Usually this equates to months 1, 2 and 3, unless the patient had any trouble attending a certain date.
Overall trial start date
01/09/2012
Overall trial end date
01/05/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age between 18-85 years old
2. Stable analgesic medication
3. Average pain levels >4 out of 10 on visual analogue scale (VAS) for pain during the one-week run-in phase, based on patient diary
4. Willingness to take part and ability to consent in study
5. Previously had a minimum of 5 sessions of TMS for pain, and can be named as a 'responder' or 'non-responder'. Responder: reporting a minimum pain reduction of 2 on a visual analogue scale (VAS) of 0-10, in at least 3 out of 5 rTMS sessions.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
24
Participant exclusion criteria
1. Severe pain of other origin (e.g., musculoskeletal pain) which in the opinion of the investigator may interfere with the reporting of the neuropathic pain being targeted
2. Metal implants/coils/electronic devices
3. Drug or alcohol abuse
4. Pregnancy
5. Psychiatric or psychological disorders
6. Epilepsy
7. Inability to understand instructions or operate equipment
8. Uncontrolled medical conditions (e.g., active cancer, uncontrolled renal, pulmonary or cardiac disease)
Recruitment start date
01/09/2012
Recruitment end date
01/05/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Pain Research Institute
Liverpool
L9 7AL
United Kingdom
Funders
Funder type
University/education
Funder name
Royal College of Physicians and Surgeons of Glasgow (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
Basic results (scientific)
Publication list
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25902771