Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia

Stanford University

Status: Completed

Conditions: Fibromyalgia

Treatments: Device: MagPro TMS system (MagVenture, Denmark); Behavioral: Hypnosis

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02969707

38138

1R33AT009305-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

• During the course of the study and upon consultation with the manufacturer, sham setting intensity was lowered to reduce the risk adverse events (e.g., scalp damage).

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.

Enrollment: 101 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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101 participants in 2 patient groups

Active rTMS

Experimental group

Description:

The active group will receive repetitive Transcranial Magnetic Stimulation

Treatment:

Behavioral: Hypnosis

Device: MagPro TMS system (MagVenture, Denmark)

Sham rTMS

Sham Comparator group

Description:

The sham repetitive Transcranial Magnetic Stimulation group will have the stimulation blocked.

Treatment:

Behavioral: Hypnosis

Device: MagPro TMS system (MagVenture, Denmark)