Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia
| Status: | Recruiting |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/20/2019 |
| Start Date: | April 24, 2017 |
| End Date: | March 2021 |
| Contact: | Merve Gulser, B.S. |
| Email: | mgulser@stanford.edu |
| Phone: | (650)736-2233 |
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.
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.
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.
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.
Inclusion Criteria:
- Fulfill 2010 Fibromyalgia Diagnostic Criteria
- Age 18 - 70
- Right-handed
- Agree to and able to have two fMRI scans as well as rTMS sessions
- Willingness to suspend use of analgesic drugs or cough suppressants for 24 hours prior
to the scans
- Willingness to suspend us of antidepressant drugs for 2 weeks prior to the scans (6
weeks for fluoxetine)
- Proficiency in English sufficient to complete questionnaires/follow instructions
during fMRI assessments
- US Citizen or resident able to receive payment legally
- Low-Moderate Hypnotizability in the Hypnotic Induction Profile (score of 0-8)
- Normal color vision
- Women of childbearing potential must agree to use adequate contraception prior to
study entry and continue this for the duration of the study
Exclusion Criteria:
- A medical condition that would contraindicate the use of rTMS
- Any condition that would contraindicate MRI (like ferromagnetic metal in the body)
- Pregnancy or breast feeding
- Any significant neurologic disease, including dementia, multi-infarct dementia,
Parkinson's or Huntington's disease, brain tumor, progressive supranuclear palsy,
seizure disorder, subdural hematoma, multiple sclerosis, history of significant head
trauma
- Current antidepressant use (must be washed out for two weeks prior to starting
protocol)
- Inability to stop taking medication contraindicated with treatment
- High Hypnotizability in the Hypnotic Induction Profile (score >8)
- Any significant psychiatric disorder as identified on the Mini Mental State Exam
(Dysthymia not an exclusion criteria)
- Color blindness
- Any significant psychiatric disorder as identified on the Mini International
Neuropsychiatric Interview
- Previous exposure to rTMS
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