Transcranial Direct Stimulation in Chronic Pelvic Pain
2020年4月22日 更新者：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.
調査の概要
詳細な説明
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).
研究の種類
介入
入学 (実際)
35
段階
- フェーズ2
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Spaulding Rehabilitation Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～64年 (大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
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偽コンパレータ：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.
他の名前：
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実験的：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.
他の名前：
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実験的：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.
他の名前：
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実験的：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.
|
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.
他の名前：
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Pain Assessment
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Quality of Life Scale (QOLS)
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2010年4月1日
一次修了 (実際)
2012年12月1日
研究の完了 (実際)
2013年5月1日
試験登録日
最初に提出
2010年4月20日
QC基準を満たした最初の提出物
2010年6月11日
最初の投稿 (見積もり)
2010年6月14日
学習記録の更新
投稿された最後の更新 (実際)
2020年4月24日
QC基準を満たした最後の更新が送信されました
2020年4月22日
最終確認日
2020年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Transcranial Direct Current Stimulationの臨床試験
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University of North Carolina, Chapel HillNational Institute of Mental Health (NIMH)完了