NCT01598181

Brief Summary

The purpose of this study is to investigate Transcranial Direct Current Stimulation as treatment method for pain in fibromyalgia.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 15, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

February 16, 2017

Status Verified

June 1, 2016

Enrollment Period

1.5 years

First QC Date

March 15, 2012

Last Update Submit

February 15, 2017

Conditions

Fibromyalgia

Outcome Measures

Primary Outcomes (1)

  • Perceived pain

    Pain (intensity and unpleasentness) measured with Visual Analog Scale. Repported at 3 points daily (0900hrs, 1500hrs, 2100hrs) using Short Message System (SMS) 14 days pre-treatment (baseline), during treatment 5 days, and 30 days post-treatment. Measure effect of active\\sham tDCS on pain. 2 levels of group (active tDCS\\ sham tDCS, 7 repeated measures: pre-treatment day 1, 2 ,3, 4, 5 - post) SMS messages contain 4 questions, mesauring pain intensity / pain unpleasentness (primary outcome), and stress / activation (secondary outcome).

    Change in VAS from baseline up to 49 days.

Secondary Outcomes (5)

  • Cerebral pain processing

    Change from baseline to post treatment. 7 days.

  • Rating scales (HADS, SCL90, SF36, FIQ)

    Change from baseline to post treatment. 30 days post treatment. Up to 65 days.

  • Perceived pain, natural history

    Baseline compared to post-treatment. Up to 65 days

  • Perceived stress and activation

    Change in VAS from baseline to during treatment and after treatment. Up to 49 days.

  • Perceived stress and activation, natural history

    Baseline compared to post-treatment. Up to 65 days

Study Arms (2)

active tDCS

EXPERIMENTAL
Device: tDCS NeuroConn DC-stimulator plus

sham tDCS

SHAM COMPARATOR

tDCS fades out after 20 sec. administered double blind by coded program.

Device: tDCS NeuroConn DC-stimulator plusDevice: sham tDCS

Interventions

tDCS NeuroConn DC-stimulator plusDEVICE

Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.

Also known as: model 0021, serial-no 0337
active tDCSsham tDCS
sham tDCSDEVICE

similar montage and time as active. Stimulation fades out after 20 sec.

sham tDCS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Fibromyalgia (ACR-90 criteria, M79.7 ICD10)
  • Mean VAS \> 4 daily 2 weeks prior to study).

You may not qualify if:

  • Severe mental disease
  • CNS disease
  • Mental retardation
  • Age \< 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Tromsoe, 9038, Norway

Location

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Per Aslaksen, ph.d

    University of Tromso

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2012

First Posted

May 15, 2012

Study Start

December 1, 2011

Primary Completion

June 1, 2013

Study Completion

October 1, 2013

Last Updated

February 16, 2017

Record last verified: 2016-06

Locations

NO(1)