Evaluation of a mobile transcranial direct current stimulation device in chronic pain

ISRCTN ISRCTN56839387
DOI https://doi.org/10.1186/ISRCTN56839387
Secondary identifying numbers UoL000869 RG030/12
Submission date
10/01/2014
Registration date
27/01/2014
Last edited
11/01/2019
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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 O’Neill
foneill@liv.ac.uk

Contact information

Dr Francis O'Neill
Scientific

The Pain Research Institute
Clinical Sciences Centre
Lower Lane
Fazackerley
Liverpool
L9 7AL
United Kingdom

Study information

Study designRandomised sham controlled double crossover trial
Primary study designInterventional
Secondary study designRandomised cross over trial
Study setting(s)Hospital
Study typeQuality of life
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEvaluation of a mobile transcranial direct current stimulation device in chronic pain: a randomised controlled trial
Study objectivesIt 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(s)NRES Committee East of England - Cambridge East, 17/07/2012, ref: 12/EE/0315
Health condition(s) or problem(s) studiedNeuropathic pain
InterventionTranscranial 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 typeDevice
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)
Primary outcome measureChange 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 measures1. 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 study start date01/09/2012
Completion date01/05/2015

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit85 Years
SexBoth
Target number of participants24
Key inclusion criteria1. 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.
Key exclusion criteria1. 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)
Date of first enrolment01/09/2012
Date of final enrolment01/05/2015

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

The Pain Research Institute
Liverpool
L9 7AL
United Kingdom

Sponsor information

University of Liverpool (UK)
University/education

University of Liverpool/Walton Centre NHS Foundation Trust
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom

ROR logo "ROR" https://ror.org/04xs57h96

Funders

Funder type

University/education

Royal College of Physicians and Surgeons of Glasgow (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol article protocol 23/04/2015 Yes No
Results article results 10/12/2018 Yes No

Editorial Notes

26/05/2016: Publication reference added.