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The purpose of this study is to determine whether transcranial direct current stimulation (tDCS) is effective in reducing pain in subjects with chronic pelvic pain. Our hypothesis is that tDCS will decrease pain significantly when compared to sham stimulation.
The study encompasses two experiments: The first one involves patients with chronic pain, receiving 10 sessions of stimulation, active or sham (parallel design).
The second experiment involves involves healthy subjects, receiving active or sham tDCS over the primary motor cortex (crossover design).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS - pelvic pain patients | Sham Comparator | ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode will be placed over the primary motor cortex of the predominantly painful side. |
|
| Sham tDCS - pelvic pain patients | Experimental | SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode will be placed over the primary motor cortex of the predominantly painful side. |
|
| Active tDCS - healthy | Experimental | The healthy controls will undergo one day of treatment with active tDCS. All participants will receive both active and sham stimulation in a randomized order. |
|
| Sham tDCS - healthy | Experimental | The healthy controls will undergo one day of treatment with sham tDCS. All participants will receive both active and sham stimulation in a randomized order. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcranial Direct Current Stimulation | Device | Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Assessment | We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS). | baseline and at 2 weeks |
| Pressure Pain Threshold | Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. The change in pressure pain threshold (post minus pre intervention) is use for the analysis. | baseline and at 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Scale (QOLS) | The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL. | 2 weeks |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Fregni, MD, PhD | Spaulding Rehabilitation Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spaulding Rehabilitation Hospital | Boston | Massachusetts | 02114 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pelvic Pain, Active tDCS | Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes. |
| FG001 | Pelvic Pain, Sham tDCS | Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA. |
| FG002 | Healthy Controls: Active tDCS/Sham tDCS | Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period. |
| FG003 | Healthy Subjects: Sham tDCS/Active tDCS | Healthy Controls: These subjects received one single session of sham tDCS and one single session of active tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received sham stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Active tDCS - Pelvic Pain | Experimental Group: Subjects received a total of 10 consecutive sessions of active tDCS over a two-week period (administered Monday - Friday). During each session, the anode electrode was placed over the primary motor cortex of the predominantly painful side. tDCS was delivered for 20 minutes at an intensity of 2mA. In the active group current was applied for the full 20 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Pain Assessment | We use the Visual analogue scale (VAS) to measure pain. The VAS is ranged from 0 to 10, with 0 reffering to no pain and 10 reffering the the worst possible pain. We used the difference between post treatment minus baseline to compare the two treatments (active versus sham tDCS). | The VAS is performed in patients with pelvic pain (Experiment 1). | Posted | Mean | Standard Deviation | units on a scale | baseline and at 2 weeks |
|
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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 | SHAM tDCS - Pelvic Pain Patients | SHAM tDCS: Subjects will receive a total of 10 consecutive sessions of sham tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side. For sham-controlled tDCS subjects, the current will be applied only for 30 seconds. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tingling | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Felipe Fregni, Director of the Laboratory of Neuromodulation | Spaulding Rehabilitation Hospital, Boston, MA. | 617.952.6153 | info@neuromodulationlab.org |
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| ID | Term |
|---|---|
| D017699 | Pelvic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| D004558 | Electric Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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For the experiment in patients with pelvic pain, the design is parallel. For the experiment in healthy subjects, the design is crossover.
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|
| Clinical Global Impression - CGI |
This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement. |
| 2 weeks |
| Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain | The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). | 2 weeks |
| Mini Mental Scale - MMS | This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status. | 2 weeks |
| Beck Depression Inventory - BDI. | BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression). | 2 weeks |
| Patient Global Assessment - PGA | This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question "how is your health overall" on a scale going from 0 to 10 (0 being the worst, 10 being the best). | 2 weeks |
| Von Frey | This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus. | baseline and at 2 weeks |
| Pain Pressure Threshold Test - PPT | Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). | baseline and at 2 weeks |
| Diffuse Noxious Inhibitory Controls - DNIC. | DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). | baseline and at 2 weeks |
| BG001 | Sham tDCS - Pelvic Pain | Sham Comparator: Subjects received a total of 10 consecutive sessions of sham tDCS over a two-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA. |
| BG002 | Active tDCS&Sham tDCS - Healthy Controls | Healthy Controls: These subjects received one single session of active tDCS and one one single session of sham tDCS. There was a time interval of at least one week in between the randomized stimulation sessions to prevent a carryover effect. This group received active stimulation first. Subjects received stimulation for 20 minutes at an intensity of 2mA. In the sham condition, current was only applied for the first 30 seconds and remained off for the rest of the 20 minute period. |
| BG003 | Total | Total of all reporting groups |
| Participants |
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| Sex/Gender, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Pelvic Pain, Sham tDCS | Sham Comparator: Subjects received a total of 20 consecutive sessions of sham tDCS over a four-week period (administered Mon-Fri). During each session, the anode was placed over the primary motor cortex of the predominantly painful side. Each tDCS session lasts 20 minutes. However, during sham stimulation current was only applied for 30 seconds at an intensity of 2mA. |
|
|
| Primary | Pressure Pain Threshold | Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain. The change in pressure pain threshold (post minus pre intervention) is use for the analysis. | The pain pressure test is performed in healthy participants (exp 2). | Posted | Mean | Standard Deviation | lb | baseline and at 2 weeks |
|
|
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| Secondary | Quality of Life Scale (QOLS) | The questionnaire on quality of life was performed at the end of the treatment session and compared between the two groups (active and sham) in patients with pelvic pain (Exp. 1). The QOLS has 16 items (total scores ranging from 16 to 112) the highest scores corresponding the best QOL. | We compared active and sham groups (Exp. 1) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Clinical Global Impression - CGI | This scale measures illness severity and was performed on patients with pelvic pain (Exp. 1). The scale was performed at end of the treatment and compared between the two groups (real and sham). The scale is divided in 3 sub-scales: Severity of illness (0-7), global improvement (0-7) and efficacy index (0-16), total scores ranging from 0 to 30. The highest scores corresponding to lowest clinical improvement. | Patients with pelvic pain (Exp 1) | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Visual Analogue Scale - Anxiety.This Scale Measures Patients' Level of Anxiety on a Scale (0-no Anxiety to 10-worst Anxiety Ever). It Was Performed at the End of the Treatment and Compared Between the 2 Groups (Real and Sham) in Patients With Pelvic Pain | The scale was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). | This outcome measure was performed in patients with pelvic pain (Exp 1). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Mini Mental Scale - MMS | This scale measures patients cognitive impairment. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 30 points scale (total scores ranging from 0 to 30), the highest score corresponds to the highest cognitive status. | Patients with pelvic pain (Exp. 1). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Beck Depression Inventory - BDI. | BDI is a questionnaire used for detecting depression. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). It is a 21-question multiple-choice self-report inventory (scores ranging from 0 to 63 - 0 corresponds to no symptom of depression). | Patients with pelvic pain (Exp. 1). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Patient Global Assessment - PGA | This scale measures patient's assessment of general health. It was performed at the end of the treatment and compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). The patient has to answer the question "how is your health overall" on a scale going from 0 to 10 (0 being the worst, 10 being the best). | Patients with pelvic pain (Exp. 1). | Posted | Mean | Standard Deviation | units on a scale | 2 weeks |
|
|
|
| Secondary | Von Frey | This test is used to test subjects' sensitivity to a mechanical stimulus. It was performed before and and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). A set of filaments, typically from 0.008 grams force up to 300 grams force, is applied on the patients' skin. The mechanical threshold is defined as the moment when the patient detects the stimulus. | Patients with pelvic pain (Exp. 1). | Posted | Mean | Standard Deviation | grams | baseline and at 2 weeks |
|
|
|
| Secondary | Pain Pressure Threshold Test - PPT | Pressure pain threshold (PPT) is defined as the minimum force applied which induces pain.This test was applied before and after the treatment and the difference (post minus pre) was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp 1). | Patients with pelvic pain (Exp. 1). | Posted | Mean | Standard Deviation | lb | baseline and at 2 weeks |
|
|
|
| Secondary | Diffuse Noxious Inhibitory Controls - DNIC. | DNIC occurs when response from a painful stimulus (pain pressure threshold - PPT) is inhibited by another noxious stimulus (cold water). The difference between baseline and post treatment was compared between the 2 groups (real and sham) in patients with pelvic pain (Exp. 1). | patients with pelvic pain (Exp. 1). | Posted | Mean | Standard Deviation | lb | baseline and at 2 weeks |
|
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|
| 0 |
| 4 |
| 3 |
| 4 |
| EG001 | ACTIVE tDCS - Pelvic Pain Patients | ACTIVE tDCS: Subjects will receive a total of 10 consecutive sessions of active tDCS. During each session, the anode electrode will be placed on the primary motor cortex of the predominant painful side. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes. | 0 | 5 | 5 | 5 |
| EG002 | SHAM tDCS - Healthy | SHAM tDCS: Subjects will receive a single session of sham tDCS. The anode electrode will be placed on the primary motor cortex. For sham-controlled tDCS subjects, the current will be applied only for 30 seconds. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes. | 0 | 15 | 11 | 15 |
| EG003 | ACTIVE tDCS - Sham | ACTIVE tDCS: Subjects will receive a single session of active tDCS. The anode electrode will be placed on the primary motor cortex. Transcranial Direct Current Stimulation: Stimulation will be given at 2 mA for a period of 20 minutes. | 0 | 15 | 15 | 15 |
| Headache | Nervous system disorders | Systematic Assessment |
|
| Neck pain | Nervous system disorders | Systematic Assessment |
|
| Skin redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Sleepiness | Nervous system disorders | Systematic Assessment |
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| Diziness | Nervous system disorders | Systematic Assessment |
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| Scalp burning sensation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Trouble concentrating | Nervous system disorders | Systematic Assessment |
|
| Acute mood change | Nervous system disorders | Systematic Assessment |
|
| Nausea | General disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
| D010812 | Physical Stimulation |
| D008919 | Investigative Techniques |