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 : February 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fibromyalgia||Device: repetitive Transcranial Magnetic Stimulation Device: Sham repetitive Transcranial Magnetic Stimulation||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|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|
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
- 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.
- 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).
- 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.
- Metabolic alterations in fibromyalgia [ Time Frame: Baseline ]To determine the association between metabolic concentrations and clinical pain measures.
- Metabolic changes in hypnotic analgesia pre- and post-rTMS [ Time Frame: Baseline and 2 hours ]To determine the relationship between the metabolic alterations pre and post-rTMS and the association with hypnotic analgesia.
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
|Contact: Merve Gulser, B.S.||(650)firstname.lastname@example.org|
|Contact: James Bishop, Ph.D.||email@example.com|
|United States, California|
|Palo Alto, California, United States, 94305|
|Contact: Merve Gulser, BS 650-736-2233 firstname.lastname@example.org|
|Principal Investigator:||Nolan Williams, M.D.||Stanford University|