NCT01226082

Brief Summary

tDCS is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.Several studies have demonstrated that tDCS applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients. The aim of this study was to test whether daily sessions of anodal tDCS repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients. The cathode is usually applied over the right forhead above the eye. The aim of the study is to test whether daily sessions of tDCS repeated for 5 consecutive days will influence on ophthalmologic parametrs.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

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 10, 2010

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 21, 2010

Completed
11 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
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

October 21, 2010

Status Verified

October 1, 2010

Enrollment Period

1 year

First QC Date

October 10, 2010

Last Update Submit

October 20, 2010

Conditions

Outcome Measures

Primary Outcomes (1)

  • Ophtalmologic examination parameters-visual acuity test, eye movement, field of vision, Tonometry (Intraocular Pressure Testing)

    5 days

Secondary Outcomes (1)

  • Pain relief

    5 days

Study Arms (1)

Transcranial Direct Current Stimulation

EXPERIMENTAL
Device: Transcranial Direct Current Stimulation

Interventions

Patients will recieve tDCS in a 5-day period of treatment

Also known as: tDCS
Transcranial Direct Current Stimulation

Eligibility Criteria

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

You may qualify if:

  • patients who suffer from chronic pain VAS\>4

You may not qualify if:

  • pregnancy
  • scalp lacerations
  • history of seizures
  • metal implants in the head
  • heart pace maker
  • ophthalmologic disease.
  • The presence of deep brain stimulation system

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tel Aviv Sourasky Medical Center, Pain Medicine Unit

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Silviu Brill, MD

    Tel-Aviv Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 10, 2010

First Posted

October 21, 2010

Study Start

November 1, 2010

Primary Completion

November 1, 2011

Study Completion

November 1, 2011

Last Updated

October 21, 2010

Record last verified: 2010-10

Locations