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The aim of this study is to use a brain stimulation tool called transcranial direct current stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily influence the way the stimulated part of the brain functions. With this method, the involvement of specific parts of the brain can be investigated in the working of the brain as a whole.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tDCS Enhancement | Experimental | In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity. |
|
| tDCS Inhibition | Experimental | In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity. |
|
| Sham tDCS | Sham Comparator | Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation (tDCS) | Device | tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation | We investigated the effects of cathodal (inhibition) and anodal (enhancement) tDCS on rDLPFC functional connectivity (FC) with the supplementary motor area (SMA) and anterior insula. Higher Fisher Z-scores represent greater resting-state functional connectivity. | up to 2 weeks |
| fMRI Resting States Functional Connectivity Changes During Pain Stimulation | We measured changes in blood oxygen level-dependent (BOLD) activity in the brain during pain stimulation. In the outcome measure data table, "placebo contrast" indicates lidocaine - neutral and "nocebo contrast" indicates capsaicin - neutral. | up to 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS | The Gracely Sensory Scale allows participants to rate the intensity of heat pain stimuli on a scale from 0 to 20, with 0 indicating no pain sensation and 20 indicating extremely intense pain. The outcome measure data table shows mean pain ratings for the lidocaine, capsaicin, and neutral creams after enhancement, inhibition, or sham tDCS stimulation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jian Kong | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Charlestown | Massachusetts | 02129 | United States |
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18 subjects were dropped prior to randomization. Reasons for this included inconsistent or non-differentiable pain ratings to heat stimuli, pain thresholds that were too high or low, inability to finish subsequent sessions, too much discomfort with noxious stimuli, no SSN/hairstyle incompatible with tDCS, participated in a previous pain study.
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| ID | Title | Description |
|---|---|---|
| FG000 | tDCS Enhancement | In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. |
| FG001 | tDCS Inhibition | In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. |
| FG002 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Participants who completed all study sessions
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| ID | Title | Description |
|---|---|---|
| BG000 | tDCS Enhancement | In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation | We investigated the effects of cathodal (inhibition) and anodal (enhancement) tDCS on rDLPFC functional connectivity (FC) with the supplementary motor area (SMA) and anterior insula. Higher Fisher Z-scores represent greater resting-state functional connectivity. | Participants who completed all study sessions | Posted | Mean | Standard Deviation | Fisher Z value | up to 2 weeks |
|
Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | tDCS Enhancement | In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Unpleasant tDCS Sensations | Skin and subcutaneous tissue disorders | Systematic Assessment | Complaints of unpleasant tDCS sensations during MRI scan. |
The sample size for this study was relatively small.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jian Kong, Principal Investigator | Massachusetts General Hospital, Harvard Medical School | 617-726-7893 | jkong2@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 2, 2018 | May 13, 2020 | ICF_000.pdf |
| Prot | Yes | No | No | Study Protocol | Apr 30, 2019 | May 13, 2020 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2019 | May 13, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| Lidocaine cream | Other | Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). |
|
| Capsaicin cream | Other | Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). |
|
| Control cream | Other | A neutral cream will be applied on the arm as a control. |
|
| up to 2 weeks |
| Nausea during MRI scan |
|
| Subject unable to attend final session |
|
| BG001 | tDCS Inhibition | In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. |
| BG002 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline pain ratings for low pain stimuli | The Gracely Sensory Scale, which ranges from 0-20, is used to rate pain experiences. 0 indicates no pain sensation, and 20 indicates extremely intense pain. | Mean | Standard Deviation | units on a scale |
|
| Baseline pain ratings for moderate pain stimuli | The Gracely Sensory Scale, which ranges from 0-20, is used to rate pain experiences. 0 indicates no pain sensation, and 20 indicates extremely intense pain. | Mean | Standard Deviation | units on a scale |
|
| Baseline pain ratings for high pain stimuli | The Gracely Sensory Scale, which ranges from 0-20, is used to rate pain experiences. 0 indicates no pain sensation, and 20 indicates extremely intense pain. | Mean | Standard Deviation | units on a scale |
|
| OG001 | tDCS Inhibition | In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. |
| OG002 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). |
|
|
| Primary | fMRI Resting States Functional Connectivity Changes During Pain Stimulation | We measured changes in blood oxygen level-dependent (BOLD) activity in the brain during pain stimulation. In the outcome measure data table, "placebo contrast" indicates lidocaine - neutral and "nocebo contrast" indicates capsaicin - neutral. | Participants who completed all study sessions and whose task fMRI data had no issues. | Posted | Mean | Standard Deviation | Arbitrary unit | up to 2 weeks |
|
|
|
| Secondary | Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS | The Gracely Sensory Scale allows participants to rate the intensity of heat pain stimuli on a scale from 0 to 20, with 0 indicating no pain sensation and 20 indicating extremely intense pain. The outcome measure data table shows mean pain ratings for the lidocaine, capsaicin, and neutral creams after enhancement, inhibition, or sham tDCS stimulation. | Participants who completed all study sessions | Posted | Mean | Standard Deviation | units on a scale | up to 2 weeks |
|
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 2 |
| 28 |
| EG001 | tDCS Inhibition | In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). Control cream: A neutral cream will be applied on the arm as a control. | 0 | 30 | 0 | 30 | 1 | 30 |
| EG002 | Sham tDCS | Sham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if results of this study are due to tDCS or other reasons. transcranial direct current stimulation (tDCS): tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds. Lidocaine cream: Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia). Capsaicin cream: Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia). | 0 | 27 | 0 | 27 | 0 | 27 |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment | Participant complained of nausea during MRI scan |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
|
| BOLD activity in the left insula: placebo contrast |
|
| BOLD activity in the left insula: nocebo contrast |
|
|
| Pain rating on neutral cream |
|
Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for lidocaine before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2.
| To assess the modulation effects of tDCS on nocebo, we first performed an analysis of covariance (ANCOVA) with nocebo as the dependent variable and group (i.e., anodal, cathodal, and sham tDCS) as the fixed factor. | ANCOVA | 0.04 | The threshold for significance was <0.05. | Mean Difference (Final Values) | 1.3 | 2-Sided | The mean difference between anodal vs. sham was 1.4, between cathodal vs. sham was 1.0, and between anodal vs. cathodal was -0.3. | Superiority | Covariates included 1) age, 2) cream randomization, and 3) the difference in ERS for capsaicin before and after expectancy manipulation (which represented how well the expectancy was modulated) in Session 2. In addition, we added the STAI state and trait anxiety scores as covariates when assessing the modulation effects of tDCS on the nocebo effect, as previous studies have suggested that anxiety level could affect nocebo hyperalgesia. |