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Trial record 51 of 106 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia

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ClinicalTrials.gov Identifier: NCT02969707
Recruitment Status : Recruiting
First Posted : November 21, 2016
Last Update Posted : April 9, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
David Spiegel, Stanford University

Brief 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.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: repetitive Transcranial Magnetic Stimulation Device: Sham repetitive Transcranial Magnetic Stimulation Not Applicable

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.


Study Type : Interventional
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia
Actual Study Start Date : April 24, 2017
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Active rTMS
The active group will receive repetitive Transcranial Magnetic Stimulation
Device: repetitive Transcranial Magnetic Stimulation
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.
Other Name: rTMS
Sham Comparator: Sham rTMS
The sham repetitive Transcranial Magnetic Stimulation group will have the stimulation blocked.
Device: Sham repetitive Transcranial Magnetic Stimulation
This will be identical to active rTMS except the stimulation will be blocked. Both active and sham repetitive Transcranial Magnetic Stimulation will receive simulation from a specially designed coil which is capable of delivering either active rTMS or sham rTMS in a manner, which is randomized by the system itself and therefore blinded to the treater.
Other Name: Sham rTMS



Primary Outcome Measures :
  1. The change in functional connectivity between the L-DLPFC and the dACC [ Time Frame: Baseline, post-TMS and during hypnotic induction ]
    The investigators will use fMRI to determine the effect of active, inhibitory rTMS (continuous theta-burst stimulation-cTBS) over left dorsolateral prefrontal cortex (L-DLPFC) on modulating the neural network that underlies hypnotizability and hypnosis.


Secondary Outcome Measures :
  1. The change in the neural network underlying hypnotic intensity [ Time Frame: Baseline and 2 hours ]
    BOLD and interleaved TMS-BOLD will be used to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on modulating the neural network that underlies hypnotic intensity.

  2. Hypnotic Induction Profile [ Time Frame: Baseline and 2 hours ]
    The investigators will use the Hypnotic Induction Profile (HIP) to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on enhancing hypnotizability.

  3. The Hypnosis Intensity Scale [ Time Frame: Baseline and 2 hours ]
    The investigators will use the Hypnotic Intensity Scale (HIS) to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on enhancing hypnotic intensity.

  4. The change in the neural network underlying the conflict regulation system [ Time Frame: Baseline and 2 hours ]
    The investigators will use fMRI to determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on the neural network underlying the conflict regulation system as a surrogate of effective modulation of the neural circuitry that underlies hypnotizability.

  5. Stroop task [ Time Frame: Baseline and 2 hours ]
    To determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on the neural network that underlies the hypnotic Stroop modulation Effect.

  6. The Numeric Pain Rating Scale [ Time Frame: Baseline and 2 hours ]
    To determine the effect of active, inhibitory rTMS (cTBS) over L-DLPFC on modulating the neural network that underlies hypnotic analgesia (HA).

  7. Sense of Agency Rating Scale (SOARS) [ Time Frame: Baseline and 2 hours ]
    To determine the correlation between the effortlessness scores on the SOARS and the Stroop task as well as the involuntariness scores with both the arm levitation score on the HIP and accelerometer data from an Apple watch worn by the participant during the HIP.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 blindnes
  • Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview
  • Previous exposure to rTMS

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969707


Contacts
Contact: Katy Stimpson, B.S. (650)736-2233 kstimpso@stanford.edu
Contact: Danielle DeSouza, Ph.D. desouzad@stanford.edu

Locations
United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: Katy Stimpson, BS    650-736-2233    kstimpson@stanford.edu   
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Investigators
Principal Investigator: Nolan Williams, M.D. Stanford University

Publications:

Responsible Party: David Spiegel, Willson Professor and Associate Chair of Psychiatry & Behavioral Sciences, Director of the Center on Stress and Health, and Medical Director of the Center for Integrative Medicine at Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT02969707     History of Changes
Other Study ID Numbers: 38138
1R33AT009305-01 ( U.S. NIH Grant/Contract )
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by David Spiegel, Stanford University:
repetitive Transcranial Magnetic Stimulation
functional MRI
Fibromyalgia
Hypnosis
Pain Assessment

Additional relevant MeSH terms:
Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs