None listed
Conditions
Brief summary
What is the project about? The TMaC study aims to permanently reduce nerve pain caused by bowel cancer treatment, a condition called chemotherapy-induced peripheral neuropathy (CIPN). CIPN has no effective treatments, so we are testing a non-invasive brain modulation therapy called repetitive transcranial magnetic stimulation (rTMS). We will be the first to determine the duration of pain improvement using TMS and work towards further expanding this approach for cancer survivors. Who is it for? You may be eligible for this study if you are an adult (aged from 18 to 85 years old) experiencing chronic pain and/or changes in sensation in your hands or feet following chemotherapy treatment for bowel cancer. What are the study details? Participants will be randomised to receive four sessions of rTMS or sham stimulation, with each session lasting 15 minutes and separated by at least seven days. The brain stimulation procedure is non-invasive and painless. You will be asked to rate chemotherapy-induced pain intensity before and after intervention. You will be followed up at 8 weeks after completion of all treatment sessions to see whether analgesic effects of rTMS are maintained. If so, there will be an additional follow-up at 6 months to assess long-term effectiveness of the intervention. It is hoped that the findings from this study will deepen our understanding of the long-term analgesic effects of rTMS, potentially offering a permanent solution to the debilitating CIPN-associated pain in cancer survivors.
Interventions
Repetitive transcranial magnetic stimulation (rTMS) applied by the experimenter on each participant’s pain-associated cortex once a week for a total of four weeks in the Integrative Neurophysiology Lab within the University of Adelaide.
Using a figure-8 coil connected to two Magstim 2002 magnetic stimulators through a Bistim module (Magstim, Dyfed, UK) in a posterior/anterior orientation, the experimenter will apply rTMS over the primary somatosensory cortex (S1), contralateral to the side of t
Repetitive transcranial magnetic stimulation (rTMS) applied by the experimenter on each participant’s pain-associated cortex once a week for a total of four weeks in the Integrative Neurophysiology Lab within the University of Adelaide. Using a figure-8 coil connected to two Magstim 2002 magnetic stimulators through a Bistim module (Magstim, Dyfed, UK) in a posterior/anterior orientation, the experimenter will apply rTMS over the primary somatosensory cortex (S1), contralateral to the side of the most-affected extremity identified by each patient. S1 in participants will be delimited at a point 2 cm posterior to the hotspot of the first dorsal interosseous (FDI) muscle. The hotspot is defined at the position on S1 with the largest and most consistent response elicited by TMS for the FDI muscle. The intensity of the stimulation will be set to produce a paired-pulse motor evoked potential of 0.5-1.5 mV. To ensure ensuring intervention fidelity, Neuronavigation system (Brainsight, UK) will be used to enhance the precision and accuracy of TMS by providing real-time guidance to the target brain area. rTMS intervention consists of 180 paired pulses with the interstimulus interval (ISI) set at 1.5 milliseconds, applied every 5 seconds for a total of 15 minutes. The total duration of each experimental session is estimated to be approximately 1 hour. This includes time for determining the appropriate stimulation intensity and target, administering the rTMS intervention, collecting data, and addressing any potential technical difficulties. Adherence to the intervention will be monitored by recording each session time, duration and the stimulation intensity. Additionally, the application of the rTMS intervention, including the delivery of 180 pulses per session, will be logged and stored on disk for each session.
Sponsors
The University of Adelaide
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Adults (18 to 85 years old) experiencing CIPN following treatment with oxaliplatin-containing chemotherapy for bowel cancer will be eligible. 2. Patients meet inclusion criteria if they have patient-reported symptoms as moderate or above according to the NCI PRO-CTCAE scale item 39, and 30 mm or greater score on a visual analogue scale (VAS) of pain or dysesthesia intensity. 3. Chemotherapy must have been completed at least 6 months prior to study enrolment.
Exclusion criteria
1. participants with a history of epilepsy, implanted cardiac pacemakers, implanted neurostimulators and metallic implants will be excluded (As determined by TMS screening questionnaire will be administered). 2. Any pre-existing neuropathic condition present prior to cancer treatment and any other reasonable cause for a painful neuropathy (such as diabetes or alcohol dependence/misuse) or continuing use of axonal neurotoxic medications.
Outcome results
None listed