Accelerated intermittent theta burst transcranial magnetic stimulation of the dorsolateral prefrontal cortex for chronic knee osteoarthritis pain.
Duncan J Hodkinson, Marianne M Drabek, Suzanne Horvath...
https://pubmed.ncbi.nlm.nih.gov/40118759/Actively Recruiting
Led by Hospital Ambroise Paré Paris · Updated on 2026-08-10
30
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating two non-invasive brain stimulation techniques, high frequency repetitive transcranial magnetic stimulation rTMS and accelerated intermittent theta burst stimulation aiTBS, to reduce chronic neuropathic pain lasting at least 6 months. This randomized controlled trial with a crossover design compares these methods to sham stimulation, aiming to assess their analgesic effects and identify factors predicting treatment response. The study includes adults aged 18 to 80 with neuropathic pain and uses brain stimulation targeting pain-related brain regions. The trial involves two treatment phases where participants receive either active or sham stimulation. Active rTMS consists of 5 daily sessions over 5 consecutive days, each lasting 25 to 30 minutes with 1500 pulses per session. Active aiTBS delivers 5 sessions in a single day with breaks between sessions, each lasting about 8 minutes and also delivering 1500 pulses per session. Sham stimulation mimics the active treatments but uses an inactive coil face and low-intensity electrical stimulation to maintain blinding. A 4 to 6-week washout period separates the two treatment phases. Participants undergo about 11 to 12 in-person visits over 10 to 12 weeks. Assessments include self-reported pain diaries using the numeric pain rating scale, validated questionnaires on pain and quality of life, resting-state EEG, and transcranial magnetic stimulation measures of brain excitability. Researchers monitor changes in pain intensity and other outcomes from before treatment through three weeks after treatment. The study also explores neurophysiological and clinical predictors to personalize chronic pain treatment.
CONDITIONS
aiTBS and rTMS in Neuropathic Pain and Prediction of Response
N
Nadine ATTAL
L
Lorenzo Sargolini, PhD Fellow
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Hospital Ambroise Paré Paris
Lead Sponsor
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Duration - 2 to 4 weeks
Participants are screened to confirm they meet the eligibility criteria for the trial.
1 to 2 visits
Duration - 1 week
Participants receive either active or sham brain stimulation. Active rTMS is given in 5 daily sessions over 5 consecutive days, and active aiTBS is given in 5 sessions within a single day. Sham stimulation mimics these treatments without active pulses.
5 daily visits for rTMS or 1 day with multiple sessions for aiTBS
Duration - 4 to 6 weeks
Participants have a break of 4 to 6 weeks to allow effects of the first treatment to fade before starting the second treatment phase.
Periodic assessments during this period
Duration - 1 week
Participants receive the alternate stimulation treatment (active or sham) not given in the first phase, following the same schedule as the first treatment phase.
5 daily visits for rTMS or 1 day with multiple sessions for aiTBS
Duration - 3 weeks
Participants are monitored and assessed for pain and other outcomes for 3 weeks after the second treatment phase ends.
Regular follow-up visits
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/38383091/Hospital Ambroise Paré Paris
Lead Sponsor