Condition category
Nervous System Diseases
Date applied
10/01/2014
Date assigned
27/01/2014
Last edited
26/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 O’Neill
foneill@liv.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Francis O'Neill

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

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

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25902771

Publication citations

Additional files

Editorial Notes

26/05/2016: Publication reference added.