N/A
Completed N=101
Use of Repetitive Transcranial Magnetic Stimulation to Augment Hypnotic Analgesia
Source: ClinicalTrials.gov NCT02969707 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcomePrimary: The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) — 61.98; 4.16; -21.41; -13.22 Z-transformed CC — p=0.035
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Functional Connectivity (FC) Between the Left Dorsolateral Prefrontal Cortex (L-DLPFC) and the Dorsal Anterior Cingulate Cortex (dACC) |
61.98; 4.16; -21.41; -13.22; 40.56; -9.06 | 0.035 sig |
| SECONDARY The Change in the Neural Network Underlying Hypnotic Intensity |
— | — |
| SECONDARY Change in Hypnotic Induction Profile Score |
.63; .31 | 0.046 sig |
| SECONDARY Change in The Hypnosis Intensity Scale |
.475; -.128 | =.412 |
| SECONDARY The Change in Functional Connectivity (FC) Within The Neural Network Underlying Conflict Regulation. |
0.01; -0.003; 33.76; 6.39; -20.36; -10.11 | — |
| SECONDARY The Change in Stroop Performance |
0.01; -0.02; -0.04; -0.009 | — |
| SECONDARY Stroop Task |
-0.026; 0.155 | 0.037 sig |
| SECONDARY Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Performance (Correlation Coefficient) With no Hypnosis Intervention. |
0.18; -0.58 | — |
| SECONDARY Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Performance (Correlation Coefficient) With Hypnosis Intervention. |
0.16; 0.16 | — |
| SECONDARY Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Interference (Correlation Coefficient) With no Hypnosis Intervention. |
0.24; -0.44 | — |
| SECONDARY Linear Relationship Between the Change in FC of the VAN to the DMN and the Change in Stroop Interference (Correlation Coefficient) With Hypnosis Intervention. |
0.07; 0.28 | — |
| SECONDARY Change in the Numeric Pain Rating Scale |
-0.13; 0.19; -0.09; -0.05 | 0.49 |
| SECONDARY Change in Sense of Agency Rating Scale (SOARS) |
.3529; 1.1034; .8857; .2727 | =.454 |
| SECONDARY Metabolic Alterations in Fibromyalgia (FMS) Defined by Excitatory / Inhibitory Ratio |
0.10; 1.72; 0.09; 5.43; -0.06; 0.50 | 0.023 sig |
| SECONDARY Alterations in Pain Perception in Fibromyalgia |
47.8; 44.6 | — |
| SECONDARY Linear Regression of Thermal Pain Threshold to Logarithm of E/I Ratio as it Relates to Water in Fibromyalgia (Coefficient of Determination) |
0.104 | — |
| SECONDARY Linear Regression of Thermal Pain Tolerance to Logarithm of E/I Ratio as it Relates to Water in Fibromyalgia (Coefficient of Determination) |
0.104 | — |
| SECONDARY Linear Regression of Thermal Pain Threshold to Logarithm of E/I Ratio as it Relates to Creatine in Fibromyalgia (Coefficient of Determination) |
0.083 | — |
| SECONDARY Linear Regression of Thermal Pain Tolerance to Logarithm of E/I Ratio as it Relates to Creatine in Fibromyalgia (Coefficient of Determination) |
0.103 | — |
| SECONDARY Metabolic Changes in L-DLPFC Pre- and Post-rTMS |
0.487; 0.486; 0.494; 0.505; -0.075; -0.076 | 0.728 |
Eligibility 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 blindness
- Any significant psychiatric disorder as identified on the Mini International Neuropsychiatric Interview
- Previous exposure to rTMS
Data sourced from ClinicalTrials.gov (NCT02969707). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.