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Exploration of Parameters of Transcranial Direct Current Stimulation (tDCS) in Chronic Pain

23 april 2020 uppdaterad av: Felipe Fregni, Spaulding Rehabilitation Hospital

Exploration of Parameters of tDCS in Chronic Pain Patients

The purpose of this study is to assess the effects of high-definition transcranial direct current stimulation (HD-tDCS) on subjects with chronic musculoskeletal pain. The investigators hypothesize that subjects will show a decrease in pain symptoms in the active anodal stimulation group when compared to sham stimulation.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

18

Fas

  • Inte tillämpbar

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

Nej

Kön som är behöriga för studier

Allt

Beskrivning

STUDY ELIGIBILITY CRITERIA

Inclusion Criteria:

  1. Providing informed consent to participate in the study
  2. 18 to 64 years old
  3. Having chronic musculoskeletal pain (existing pain for more than 6 months with an average of at least 3 on a 0-10 VAS scale)
  4. Pain resistant to common analgesics and medications for chronic pain such as Tylenol, Aspirin, Ibuprofen, Soma, Parafon Forte DCS, Zanaflex, and Codeine.
  5. Must have the ability to feel pain as self reported

Exclusion Criteria:

  1. Pregnancy

  2. Contraindications to tDCS

    • metal in the head
    • implanted brain medical devices
  3. History of alcohol or drug abuse within the past 6 months as self reported
  4. Use of carbamazepine within the past 6 months as self reported.
  5. Severe depression (with a score of >30 in the Beck Depression Inventory)
  6. History of neurological disorders as self reported.
  7. History of unexplained fainting spells as self reported,
  8. History of head injury resulting in more than a momentary loss of consciousness as self reported
  9. History of neurosurgery 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: Enhetens genomförbarhet
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Active Anodal HD-tDCS
Subject will receive one 20-minute session of active anodal HD-tDCS.
Enhet: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.

  • For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes.
  • For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes.
  • For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)
Experimentell: Active Cathodal HD-tDCS
Subject will receive one 20-minute session of active cathodal HD-tDCS.
Enhet: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.

  • For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes.
  • For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes.
  • For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)
Sham Comparator: Sham HD-tDCS
Subject will receive one sham session of HD-tDCS
Enhet: High Definition Transcranial Direct Current Stimulation (HD-tDCS)

Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.

  • For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes.
  • For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes.
  • For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in pain scales
Tidsram: Measured for approximately 5 weeks
Determine whether anodal or cathodal hd-tDCS is effective in reducing pain in subjects with chronic musculoskeletal pain as measured by changes in the Visual Analogue Scale (VAS) for pain. The VAS scale will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for each subject for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
Measured for approximately 5 weeks

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in cutaneous hyperalgesia/allodynia
Tidsram: Measured for approximately 5 weeks.
To investigate whether treatment with active anodal hd-tDCS alters the phenomenon of central sensitization as indexed by cutaneous allodynia and hyperalgesia by measuring whether anodal tDCS changes the threshold for pain and perception as compared with sham and cathodal hd-tDCS. The subject's pain threshold will be measured immediately before the hd-tDCS stimulation sessions and after the hd-tDCS stimulation sessions for the duration of their participation in the trial. This outcome will also be measured at their baseline visit, and follow-up visit.
Measured for approximately 5 weeks.

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

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 2011

Primärt slutförande (Faktisk)

1 februari 2012

Avslutad studie (Faktisk)

13 februari 2013

Studieregistreringsdatum

Först inskickad

29 juni 2011

Först inskickad som uppfyllde QC-kriterierna

25 juli 2011

Första postat (Uppskatta)

26 juli 2011

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

24 april 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

23 april 2020

Senast verifierad

1 april 2020

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 2010-p-000990

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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