NCT01220323

Brief Summary

In the present study, the investigators intend to investigate whether anodal transcranial direct current stimulation (tDCS) may be effective in reducing pain in chronic pain patients.

Trial Health

50
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

October 6, 2010

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 13, 2010

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
Last Updated

October 13, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

October 6, 2010

Last Update Submit

October 11, 2010

Conditions

Chrronic Pain Patients

Outcome Measures

Primary Outcomes (1)

  • Pain relief

    5 days

Secondary Outcomes (1)

  • Avaluation of tDCS treatment for chronic pain on disability, depression, anxiety, and cognition of treated patients.

    5 days

Study Arms (2)

direct current stimulation

ACTIVE COMPARATOR

The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm.

Device: direct current stimulation

sham stimulation

SHAM COMPARATOR
Device: direct current stimulation

Interventions

direct current stimulationDEVICE

Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm

direct current stimulation

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • over 18
  • chronic pain patients VAS \> 4

You may not qualify if:

  • pregnancy
  • scalp lacerations
  • History of seizures
  • metal implants in the head
  • heart pace maker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 6, 2010

First Posted

October 13, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Last Updated

October 13, 2010

Record last verified: 2010-10