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Trial record 53 of 103 for:    fibromyalgia | Recruiting, Not yet recruiting, Available Studies | Interventional Studies

Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia

This study is not yet open for participant recruitment.
See Contacts and Locations
Verified January 2017 by David Spiegel, Stanford University
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
David Spiegel, Stanford University
ClinicalTrials.gov Identifier:
NCT02969707
First received: November 16, 2016
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
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 Intervention
Fibromyalgia Device: repetitive Transcranial Magnetic Stimulation Device: Sham repetitive Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by David Spiegel, Stanford University:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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).


Estimated Enrollment: 100
Anticipated Study Start Date: March 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: March 2021 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Fulfill 2010 Fibromyalgia Diagnostic Criteria
  • Age 18 - 65
  • 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)

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02969707

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

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 )
Study First Received: November 16, 2016
Last Updated: January 23, 2017
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

ClinicalTrials.gov processed this record on August 18, 2017