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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
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The purpose of this study is to see if transcranial direct current stimulation may improve the symptoms of depression.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| transcranial direct current stimulation | Active Comparator | 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. |
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| sham tDCS | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial direct current stimulation | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression). | The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks. | Two weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory II | patient self report of depressive symptoms | Two weeks |
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Inclusion Criteria:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter M Bulow, MD | New York State Psychiatric Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14211695 | Background | COSTAIN R, REDFEARN JW, LIPPOLD OC. A CONTROLLED TRIAL OF THE THERAPEUTIC EFFECT OF POLARIZATION OF THE BRAIN IN DEPRESSIVE ILLNESS. Br J Psychiatry. 1964 Nov;110:786-99. doi: 10.1192/bjp.110.469.786. No abstract available. | |
| 15753425 | Background | Iyer MB, Mattu U, Grafman J, Lomarev M, Sato S, Wassermann EM. Safety and cognitive effect of frontal DC brain polarization in healthy individuals. Neurology. 2005 Mar 8;64(5):872-5. doi: 10.1212/01.WNL.0000152986.07469.E9. |
| Label | URL |
|---|---|
| National Institute of Mental Health - Depression | View source |
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One patient was dropped by the investigator when he had a Hamilton Depression Rating Scale (HDRS) of 8 prior to baseline ratings (DRSS 20 is the minimum for inclusion in the study).
Dates of recruitment period: 2006-2009 Location: community Approved sample size: 23 Total number of participants enrolled: 19
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| ID | Title | Description |
|---|---|---|
| FG000 | Iomed II Phoresor 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. |
| FG001 | Sham Iomed II Phoresor Transcranial Direct Current Stimulation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| transcranial direct current stimulation | 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. |
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| transcranial direct current stimulation | Device | one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode |
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| iomed phoresor transcranial direct current stimulation | Device | for the sham group the current is turned off after 10 seconds |
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| Study summary on the Brain Stimulation Division web site | View source |
The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm 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. |
| Crossover |
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| COMPLETED |
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| NOT COMPLETED |
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One patient dropped out of study after 5 treatments due to One patient dropped out of study after 5 treatments to pursue other treatment options One patient dropped by investigator when patient had HDRS of 8 at baseline ratings One patient dropped out of study after 1 treatment to pursue other treatment options
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| ID | Title | Description |
|---|---|---|
| BG000 | Transcranial Direct Current Stimulation | one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation |
| BG001 | Sham tDCS | the 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hamilton Rating Scale for Depression (24 Question Version), a Standardized Assessment Tool for Measuring Severity of Depression Where 0 is the Minimum Score (no Depressive Symptoms) and 40 is the Maximum (Severe Depression). | The Hamilton Rating Scale for Depression (HRS,24 question version), is a standardized assessment tool for measuring severity of depression where 0 is the minimum score (no depressive symptoms) and 40 is the maximum (severe depression).I am reporting the number of participants with stable remission which is defined as an HDRS < 10 for 2 weeks. | 20 patients were enrolled in the study and 17 patients completed it. The 17 patients who completed the study are the population analyzed. | Posted | Number | participants | Two weeks |
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| Secondary | Beck Depression Inventory II | patient self report of depressive symptoms | Data for the secondary outcome measure was incompletely collected and not analyzed. | Posted | Two weeks |
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2 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Transcranial Direct Current Stimulation | one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation | 0 | 19 | 2 | 19 | ||
| EG001 | Sham tDCS | the 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. | 0 | 8 | 0 | 8 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| scalp burn | Injury, poisoning and procedural complications | other | Non-systematic Assessment | two of the participants suffered scalp burns under the site of the sponge electrode. These were similar to sunburns and resolved completely by the next day. These burns occurred only in subjects receiving active tDCS, not sham tDCS. |
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Data for the secondary outcome measure (Beck Depression Inventory) was incompletely collected and not analyzed.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Bulow MD, Assistant Professor of Clinical Psychiatry | Division of Experimental Therapeutics, NY State Psychiatric Organization | (212) 543 5664 | pb2182@columbia.edu |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |
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| >=65 years |
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| Male |
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