Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia
Condition: Fibromyalgia
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes
Study type: Interventional

Summary: 
      The investigators plan to use functional neuroimaging (fMRI) to understand the brain systems
      affected when hypnosis and hypnotic analgesia are augmented with repetitive transcranial
      magnetic stimulation (rTMS), a form of non-invasive brain stimulation to 100 people with
      fibromyalgia, a chronic pain condition. The investigators will measure the effect of
      rTMS-augmentation on the brain networks underlying hypnotizability, as well as the effect of
      rTMS-augmentation on hypnotic analgesia networks. The investigators hope to demonstrate that
      a combination of these psychological and neuromodulatory treatments will be more effective
      than hypnosis alone, thereby enhancing the depth of hypnosis, range of hypnosis and the
      efficacy of hypnotic analgesia and hopefully creating a new treatment modality for
      individuals suffering from pain syndromes such as fibromyalgia pain.
    

Detailed description: 
      Overall Study Design. The investigators propose to develop a combinatory approach where an
      integrative technique (hypnosis) is augmented with a neurotechnology (repetitive transcranial
      magnetic stimulation). This application seeks to utilize the previously established
      brain-based mechanisms of both hypnosis and repetitive transcranial magnetic stimulation as
      biomarkers to assess the potential synergistic mechanism of this combinatory approach. 100
      low-moderately hypnotizable subjects with fibromyalgia will be identified. The subjects'
      response to rTMS-augmentation of hypnosis will be measured. The volunteers will be randomized
      to active or sham rTMS. Two scan sessions will be performed for each subject, with the first
      scan session investigating the effect of rTMS-augmentation on hypnosis and hypnotizability
      (120 min scan session) and the second scan session focused on the effect of rTMS-augmented
      hypnotic analgesia (120 min scan session).

      The study will require that participants participate in an in-person screening visit, a
      screening MRI scan and 2 MRI scan sessions that include the TMS and hypnosis.

      Experimental design. Before each MRI scan session, participants will undergo a preparation
      session, where hypnotizability and either psychological testing or experimental pain training
      will be conducted. Volunteer subjects will then participate in 2 MRI scan sessions on two
      separate days, each lasting approximately 120 mins.

      Hypnosis induction procedures. Hypnosis will be induced while the subject is in the scanner
      though the use of headphones and a pre-recorded induction script. Hypnotic instructions will
      be standardized, and will involve a simple induction instruction used in our prior research
      on the brain signature of the hypnotic state and in clinical care. The ability to enter and
      maintain the hypnotic state through such an induction mechanism in the fMRI environment has
      been previously demonstrated.
    

Intervention name(s): MagPro TMS system (MagVenture, Denmark); Hypnosis
Intervention type(s): Device; Behavioral
Intervention description(s): The investigators will perform two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC will be determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 will be utilized for this localization process. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark). sham rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark).sham rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark).; Hypnotizability will be measured using the Hypnotic Induction Profile before and after administration of real vs. sham rTMS. Hypnotizability will be measured using the Hypnotic Induction Profile before and after administration of real vs. sham rTMS. Hypnosis will be employed to influence Stroop performance (conflict detection) and for pain management. The hypnotic instructions for this will be pre-recorded and played during fMRI.
Other intervention name(s): rTMS will be delivered using the MagPro TMS system (MagVenture, Denmark).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: repetitive Transcranial Magnetic Stimulation; functional MRI; Fibromyalgia; Hypnosis; Pain Assessment