Trial Outcomes & Findings for Transcranial Direct Stimulation in Chronic Pelvic Pain (NCT NCT01143636)

NCT ID: NCT01143636

Last Updated: 2020-04-24

Results Overview

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).

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 35 participants
• Primary outcome timeframe: baseline and at 2 weeks
• Results posted on: 2020-04-24

Participant Flow

Participant milestones

Measure	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.	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.	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.	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.
Overall Study STARTED	6	5	8	7
Overall Study COMPLETED	5	4	8	7
Overall Study NOT COMPLETED	1	1	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Direct Stimulation in Chronic Pelvic Pain

Baseline characteristics by cohort

Measure	Active tDCS - Pelvic Pain n=6 Participants 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.	Sham tDCS - Pelvic Pain n=5 Participants 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.	Active tDCS&Sham tDCS - Healthy Controls n=15 Participants 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.	Total n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	15 Participants n=5 Participants	26 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex/Gender, Customized Female	5 participants n=5 Participants	4 participants n=7 Participants	9 participants n=5 Participants	18 participants n=4 Participants
Sex/Gender, Customized Male	1 participants n=5 Participants	1 participants n=7 Participants	6 participants n=5 Participants	8 participants n=4 Participants
Region of Enrollment United States	6 participants n=5 Participants	5 participants n=7 Participants	15 participants n=5 Participants	26 participants n=4 Participants

PRIMARY outcome

Timeframe: baseline and at 2 weeks

Population: The VAS is performed in patients with pelvic pain (Experiment 1).

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).

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Pain Assessment	-2.375 units on a scale Standard Deviation 1.79	-1.625 units on a scale Standard Deviation 2.46

PRIMARY outcome

Timeframe: baseline and at 2 weeks

Population: The pain pressure test is performed in healthy participants (exp 2).

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.

Outcome measures

Measure	Pelvic Pain, Active tDCS n=15 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=15 Participants 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.
Pressure Pain Threshold	1.25 lb Standard Deviation 0.75	-1 lb Standard Deviation 0.5

SECONDARY outcome

Timeframe: 2 weeks

Population: We compared active and sham groups (Exp. 1)

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.

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Quality of Life Scale (QOLS)	81.2 units on a scale Standard Deviation 15.4	78 units on a scale Standard Deviation 11.43

SECONDARY outcome

Timeframe: 2 weeks

Population: Patients with pelvic pain (Exp 1)

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.

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Clinical Global Impression - CGI	2.8 units on a scale Standard Deviation 0.4	3.3 units on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: 2 weeks

Population: This outcome measure was performed in patients with pelvic pain (Exp 1).

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).

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
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	0.8 units on a scale Standard Deviation 0.9	2.5 units on a scale Standard Deviation 2.1

SECONDARY outcome

Timeframe: 2 weeks

Population: Patients with pelvic pain (Exp. 1).

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.

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Mini Mental Scale - MMS	29.4 units on a scale Standard Deviation 0.8	28.75 units on a scale Standard Deviation 1.1

SECONDARY outcome

Timeframe: 2 weeks

Population: Patients with pelvic pain (Exp. 1).

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).

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Beck Depression Inventory - BDI.	10 units on a scale Standard Deviation 9.7	6.75 units on a scale Standard Deviation 6.8

SECONDARY outcome

Timeframe: 2 weeks

Population: Patients with pelvic pain (Exp. 1).

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).

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Patient Global Assessment - PGA	2.8 units on a scale Standard Deviation 0.9	2.75 units on a scale Standard Deviation 1.3

SECONDARY outcome

Timeframe: baseline and at 2 weeks

Population: Patients with pelvic pain (Exp. 1).

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.

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Von Frey	0.7 grams Standard Deviation 0.76	-0.29 grams Standard Deviation 0.48

SECONDARY outcome

Timeframe: baseline and at 2 weeks

Population: Patients with pelvic pain (Exp. 1).

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).

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Pain Pressure Threshold Test - PPT	2.21 lb Standard Deviation 3.93	1.41 lb Standard Deviation 2.31

SECONDARY outcome

Timeframe: baseline and at 2 weeks

Population: patients with pelvic pain (Exp. 1).

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).

Outcome measures

Measure	Pelvic Pain, Active tDCS n=5 Participants Experimental Group: Subjects received a total of 20 consecutive sessions of active tDCS over a four-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.	Pelvic Pain, Sham tDCS n=4 Participants 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.
Diffuse Noxious Inhibitory Controls - DNIC.	2.46 lb Standard Deviation 4.84	0.66 lb Standard Deviation 2.39

Adverse Events

SHAM tDCS - Pelvic Pain Patients

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

ACTIVE tDCS - Pelvic Pain Patients

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

SHAM tDCS - Healthy

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

ACTIVE tDCS - Sham

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SHAM tDCS - Pelvic Pain Patients n=4 participants at risk 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.	ACTIVE tDCS - Pelvic Pain Patients n=5 participants at risk 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.	SHAM tDCS - Healthy n=15 participants at risk 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.	ACTIVE tDCS - Sham n=15 participants at risk 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.
Skin and subcutaneous tissue disorders Tingling	75.0% 3/4	100.0% 5/5	66.7% 10/15	73.3% 11/15
Nervous system disorders Headache	25.0% 1/4	20.0% 1/5	6.7% 1/15	6.7% 1/15
Nervous system disorders Neck pain	25.0% 1/4	20.0% 1/5	0.00% 0/15	0.00% 0/15
Skin and subcutaneous tissue disorders Skin redness	50.0% 2/4	80.0% 4/5	53.3% 8/15	46.7% 7/15
Nervous system disorders Sleepiness	25.0% 1/4	60.0% 3/5	40.0% 6/15	33.3% 5/15
Nervous system disorders Diziness	50.0% 2/4	0.00% 0/5	0.00% 0/15	0.00% 0/15
Skin and subcutaneous tissue disorders Scalp burning sensation	0.00% 0/4	20.0% 1/5	0.00% 0/15	6.7% 1/15
Nervous system disorders Trouble concentrating	0.00% 0/4	20.0% 1/5	0.00% 0/15	0.00% 0/15
Nervous system disorders Acute mood change	0.00% 0/4	20.0% 1/5	0.00% 0/15	0.00% 0/15
General disorders Nausea	0.00% 0/4	20.0% 1/5	0.00% 0/15	0.00% 0/15
Skin and subcutaneous tissue disorders Itching	0.00% 0/4	20.0% 1/5	6.7% 1/15	13.3% 2/15

Additional Information

Dr. Felipe Fregni, Director of the Laboratory of Neuromodulation

Spaulding Rehabilitation Hospital, Boston, MA.

Phone: 617.952.6153

Email: info@neuromodulationlab.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place