Treating Depression With Transcranial Direct Current Stimulation (tDCS)

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2011-01-31

Brief Summary

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The purpose of this study is to see if transcranial direct current stimulation may improve the symptoms of depression.

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Detailed Description

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The purpose of this study is to learn about a brain stimulating procedure called transcranial direct current stimulation (tDCS). In tDCS therapy, two moistened sponges are applied to the forehead while a small amount of electric current flows between them. These electrodes are placed on the head so that the electricity will pass through a region in the brain that is believed to contribute to depression. This study is intended to test the theory that the electromagnetic field created by the current may affect this region of the brain in a way that may improve the symptoms of depression. This may affect brain activity and function.

Conditions

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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transcranial direct current stimulation

The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.

Group Type ACTIVE_COMPARATOR

transcranial direct current stimulation

Intervention Type DEVICE

Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.

transcranial direct current stimulation

Intervention Type DEVICE

transcranial direct current stimulation delivers one milliamp of direct current, supplied by a constant current generator, the the left dorsolateral prefrontal cortex through a scalp electrode. The treatment is given for 20 minutes a day.

transcranial direct current stimulation

Intervention Type DEVICE

one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode

sham tDCS

The patients in the sham arm receive active Iomed II Phoresor transcranial direct current stimulation for the second two weeks of the clinical trial only. For the first two weeks the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.

Group Type SHAM_COMPARATOR

iomed phoresor transcranial direct current stimulation

Intervention Type DEVICE

for the sham group the current is turned off after 10 seconds

Interventions

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transcranial direct current stimulation

Two damp sponges, one placed on the left side of the forehead, the other on the left arm. 0.1mA of current is passed for 20 minutes.

Intervention Type DEVICE

transcranial direct current stimulation

transcranial direct current stimulation delivers one milliamp of direct current, supplied by a constant current generator, the the left dorsolateral prefrontal cortex through a scalp electrode. The treatment is given for 20 minutes a day.

Intervention Type DEVICE

transcranial direct current stimulation

one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode

Intervention Type DEVICE

iomed phoresor transcranial direct current stimulation

for the sham group the current is turned off after 10 seconds

Intervention Type DEVICE

Other Intervention Names

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ioMed Phoresor Phoresor II Auto model PM850 Phoresor II Auto model PM850 phoresor II auto model PM850

Eligibility Criteria

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Inclusion Criteria

* Has a diagnosis of a major depressive episode or bipolar disorder and is currently in a major depressive episode (without psychotic features)
* Total pretreatment HDRS (Hamilton Depression Rating Scale)-24 score \>= 18 (The Hamilton Depression Rating Scale is an interviewer scored tool for assessing the severity of depressive symtoms. The scale ranges from 0 (no symptoms, absence of depression) to 64

Category Ham-24 Score Normal, not depressed 9 or less Mildly depressed 10 to 19 Moderately depressed 20 to 29 Markedly/severely depressed 30 or more)

* Capable and willing to provide informed consent

Exclusion Criteria

* History of depression previously untreated with medication, bipolar disorder, schizophrenia, schizoaffective disorder (non mood disorder), psychosis, depression secondary to a medical condition, mental retardation, substance dependence or abuse within the past year (except nicotine), psychotic features in this or previous episodes, amnestic disorder, dementia or mms\<24, DELIRIUM
* Significant current history of autoimmune, endocrine, viral or vascular disorder affecting the brain
* History of unstable cardiac disease, uncontrolled hypertension, or sleep apnea
* Changes in psychotropic medications within two weeks prior to study entry or patient is unable to maintain stable doses throughout the study trial
* Subject has an active suicidal plan and/or attempted suicide in the past twelve months
* Patients with a CGI of 6 or greater
* Subject is pregnant or has a positive pregnancy serum test

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No