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Transcranial Direct Stimulation in Chronic Pelvic Pain

22 april 2020 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Faktisk)

35

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Förenta staterna
    • Massachusetts
      • Boston, Massachusetts, Förenta staterna, 02114
        • Spaulding Rehabilitation Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 64 år (Vuxen)

Tar emot friska volontärer

Ja

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old
  3. 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)
  4. No history of or current genitourinary tuberculosis as self reported
  5. No history of urethral cancer as self reported
  6. No history or current bladder malignancy, high grade dysplasia or carcinoma in situ as self reported
  7. No occurrence of ovarian, vaginal or cervical cancer in the previous 3 years as self reported
  8. No current vaginal infection as self reported
  9. No active herpes in previous 3 months as self reported
  10. No antimicrobials for urinary tract infections in previous 3 months as self reported
  11. Never treated with cyclophosphamide as self reported
  12. No radiation cystitis as self reported
  13. No neurogenic bladder dysfunction (due to a spinal cord injury, stroke, Parkinson's disease, multiple sclerosis, spina bifida or diabetic cystopathy) as self reported
  14. Absence of bladder, ureteral or urethral calculi for previous 3 months as self reported
  15. No urethritis for previous 3 months as self reported
  16. No urethral dilatation, cystometrogram, bladder cystoscopy with full anesthesia or bladder biopsy in previous 3 months as self reported
  17. Must not be pregnant
  18. Eligible to MRI according to MRI screening checklist
  19. No contraindications to tDCS:
  20. No history of alcohol or drug abuse within the past 6 months as self reported
  21. No use of carbamazepine as self reported
  22. Does not have severe depression (with a score of >30 in the Beck Depression Inventory)
  23. No history of neurological disorders as self reported
  24. No history of unexplained fainting spells as self reported,
  25. No history of head injury resulting in more than a momentary loss of consciousness as self reported
  26. Have had no neurosurgery as self reported
  27. No history of psychological disorders as self reported
  28. Must have the ability to feel pain as self reported

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Sham Comparator: 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.
Enhet: Transcranial Direct Current Stimulation
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.
Andra namn:
  • tDCS, electrical stimulation
Experimentell: 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.
Enhet: Transcranial Direct Current Stimulation
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.
Andra namn:
  • tDCS, electrical stimulation
Experimentell: 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.
Enhet: Transcranial Direct Current Stimulation
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.
Andra namn:
  • tDCS, electrical stimulation
Experimentell: 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.
Enhet: Transcranial Direct Current Stimulation
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.
Andra namn:
  • tDCS, electrical stimulation

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Pain Assessment
Tidsram: baseline and at 2 weeks
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
Tidsram: baseline and at 2 weeks

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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Quality of Life Scale (QOLS)
Tidsram: 2 weeks
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
Clinical Global Impression - CGI
Tidsram: 2 weeks
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
Tidsram: 2 weeks
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
Tidsram: 2 weeks
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.
Tidsram: 2 weeks
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
Tidsram: 2 weeks
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
Tidsram: baseline and at 2 weeks
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
Tidsram: baseline and at 2 weeks
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.
Tidsram: baseline and at 2 weeks
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

Samarbetspartners och utredare

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Sponsor

Spaulding Rehabilitation Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2010

Primärt slutförande (Faktisk)

1 december 2012

Avslutad studie (Faktisk)

1 maj 2013

Studieregistreringsdatum

Först inskickad

20 april 2010

Först inskickad som uppfyllde QC-kriterierna

11 juni 2010

Första postat (Uppskatta)

14 juni 2010

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

22 april 2020

Senast verifierad

1 april 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2009-P-002048

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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