Treating Depression With Transcranial Direct Current Stimulation (tDCS)
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|ClinicalTrials.gov Identifier: NCT00481988|
Recruitment Status : Completed
First Posted : June 4, 2007
Results First Posted : May 20, 2013
Last Update Posted : May 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Depression||Device: transcranial direct current stimulation Device: iomed phoresor transcranial direct current stimulation||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Randomized, Double Blind Crossover Study of the Treatment of Major Depressive Episode With Transcranial Direct Current Stimulation (tDCS)|
|Study Start Date :||March 2007|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||January 2011|
Active Comparator: 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.
Device: 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.
Other Name: ioMed PhoresorDevice: 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.
Other Name: Phoresor II Auto model PM850Device: transcranial direct current stimulation
one milliamp of direct current applied to the left dorsolateral prefrontal cortex through a scalp electrode
Other Name: Phoresor II Auto model PM850
Sham Comparator: 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.
Device: iomed phoresor transcranial direct current stimulation
for the sham group the current is turned off after 10 seconds
Other Name: phoresor II auto model PM850
- 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). [ Time Frame: Two weeks ]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.
- Beck Depression Inventory II [ Time Frame: Two weeks ]patient self report of depressive symptoms
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481988
|United States, New York|
|New York State Psychiatric Institute|
|New York City, New York, United States, 10032|
|Principal Investigator:||Peter M Bulow, MD||New York State Psychiatric Institute|