Investigation of sensory symptoms associated with TMS
Research type
Research Study
Full title
Investigation of sensory symptoms associated with Transcranial Magnetic Stimulation (TMS) in healthy volunteers and patients with neuropathic pain
IRAS ID
173165
Contact name
Paul Sacco
Contact email
Sponsor organisation
The Walton Centre NHS Foundation Trust
Duration of Study in the UK
1 years, 0 months, 6 days
Research summary
Transcranial magnetic stimulation (TMS) is a non-invasive brain stimulation technology that involves sending magnetic pulses into the superficial layer of the brain (cortex). In the last two decades it has been discovered that if TMS is administered to people with chronic pain in the form of series of pulses (repetitive TMS,or rTMS) it will lead to some physiological changes in the cortex that lead to temporary pain relief. This means that rTMS has the potential to become a therapeutic tool in clinical practice. Consequently, sham-controlled trials are now needed to establish the true efficacy of rTMS therapy. We are currently using a TMS system (Nexstim NBT) which uniquely comes with a purpose-built sham coil. The sham coil looks exactly the same and generates the same effects (in regards to noise and sensation) as the real TMS coil but generates a much smaller magnetic field. Therefore, the sham TMS has no impact on the cortex. The present study is about exploring how well the sham stimulation mimics that of real stimulation as a participant experience. We will compare real and sham rTMS in 20 healthy volunteers during two sessions, and administered in a way that neither the subject or the TMS operator knows which is in use. The participants will rate their subjective scalp and other sensations on a specific questionnaire; and they will be asked if they can guess which mode was active vs sham. In addition, up to 10 patients will be subjected to a similar comparison; their stimulation parameters based on those that appear optimal judging from the healthy volunteers' responses. It is important to include patients with neuropathic pain as they may experience different sensations during TMS in their painful area, compromising blinding.
REC name
North West - Haydock Research Ethics Committee
REC reference
15/NW/0929
Date of REC Opinion
15 Dec 2015
REC opinion
Favourable Opinion