Transcranial Direct Stimulation in Chronic Pelvic Pain
22 de abril de 2020 actualizado por: Felipe Fregni, Spaulding Rehabilitation Hospital
Investigation and Treatment of Central Nervous System Dysfunction in Chronic Pelvic Pain.
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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).
Tipo de estudio
Intervencionista
Inscripción (Actual)
35
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02114
- Spaulding Rehabilitation Hospital
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 64 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Providing informed consent to participate in the study
- 18 to 64 years old
- Having symptoms of pelvic pain for more than 6 months with an average of 3 on a 0-10 VAS scale (for pelvic pain subjects only)
- No history of or current genitourinary tuberculosis as self reported
- No history of urethral cancer as self reported
- No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
- No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
- No current vaginal infection as self reported
- No active herpes in previous 3 months as self reported
- No antimicrobials for urinary tract infections in previous 3 months as self reported
- Never treated with cyclophosphamide as self reported
- No radiation cystitis as self reported
- No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
- Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
- No urethritis for previous 3 months as self reported
- No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
- Must not be pregnant
- Eligible to MRI according to MRI screening checklist
- No contraindications to tDCS:
- No history of alcohol or drug abuse within the past 6 months as self reported
- No use of carbamazepine as self reported
- Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
- No history of neurological disorders as self reported
- No history of unexplained fainting spells as self reported,
- No history of head injury resulting in more than a momentary loss of consciousness as self reported
- Have had no neurosurgery as self reported
- No history of psychological disorders as self reported
- Must have the ability to feel pain as self reported
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador falso: Active tDCS - pelvic pain patients
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.
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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.
Otros nombres:
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Experimental: Sham tDCS - pelvic pain patients
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.
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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.
Otros nombres:
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Experimental: Active tDCS - healthy
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.
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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.
Otros nombres:
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Experimental: Sham tDCS - healthy
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.
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pain Assessment
Periodo de tiempo: baseline and at 2 weeks
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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).
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baseline and at 2 weeks
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Pressure Pain Threshold
Periodo de tiempo: baseline and at 2 weeks
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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
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Quality of Life Scale (QOLS)
Periodo de tiempo: 2 weeks
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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.
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2 weeks
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Clinical Global Impression - CGI
Periodo de tiempo: 2 weeks
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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.
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2 weeks
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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
Periodo de tiempo: 2 weeks
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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).
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2 weeks
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Mini Mental Scale - MMS
Periodo de tiempo: 2 weeks
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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.
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2 weeks
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Beck Depression Inventory - BDI.
Periodo de tiempo: 2 weeks
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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).
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2 weeks
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Patient Global Assessment - PGA
Periodo de tiempo: 2 weeks
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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).
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2 weeks
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Von Frey
Periodo de tiempo: baseline and at 2 weeks
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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.
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baseline and at 2 weeks
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Pain Pressure Threshold Test - PPT
Periodo de tiempo: baseline and at 2 weeks
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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).
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baseline and at 2 weeks
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Diffuse Noxious Inhibitory Controls - DNIC.
Periodo de tiempo: baseline and at 2 weeks
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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).
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baseline and at 2 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de abril de 2010
Finalización primaria (Actual)
1 de diciembre de 2012
Finalización del estudio (Actual)
1 de mayo de 2013
Fechas de registro del estudio
Enviado por primera vez
20 de abril de 2010
Primero enviado que cumplió con los criterios de control de calidad
11 de junio de 2010
Publicado por primera vez (Estimar)
14 de junio de 2010
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de abril de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
22 de abril de 2020
Última verificación
1 de abril de 2020
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2009-P-002048
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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