Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression (aTDCS)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
|Official Title:||Adjunctive Transcranial Direct Current Stimulation for Cognition in Major Depression|
- To test our hypotheses, assessments of cognition, mood, and brain activity will be performed on three occasions [ Time Frame: 6 visits ] [ Designated as safety issue: No ]
- ADVERSE EVENT REPORTS Subjects will be asked about adverse events at the end of each treatment session [ Time Frame: 6 visits ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2007|
|Study Completion Date:||May 2009|
|Primary Completion Date:||May 2009 (Final data collection date for primary outcome measure)|
Transcranial direct stimulation
Device: Transcranial direct stimulation
sessions of 20 minutes each
Transcranial direct current stimulation (tDCS), also sometimes termed "DC polarization" or "brain polarization," is a non-invasive procedure that has been used successfully as a therapeutic intervention in a number of patient populations. tDCS involves the passing of very weak currents through an area of interest of the brain, by placing electrodes on the scalp at the appropriate locations. DC polarization has been shown to alter the amplitude of evoked potentials in the visual cortex (Antal et al., 2004), and cortical processing in the parietal lobe also can be modulated by tDCS (Rogalewski et al., 2004). From a more physiologically-relevant perspective, tDCS of the motor cortex has been shown to improve motor function in patients following stroke (Hummel and Cohen, 2005; Hummel et al., 2006; Boggio et al., 2006b) when applied to the prefrontal cortex. tDCS has been shown to improve working memory in healthy individuals (Fregni et al., 2005b), and in individuals with major depressive episode. In MDD it has more recently been shown to improve depression rating self-report scores (Fregni et al., 2006a) and cognitive performance (Fregni et al., 2006b). Performance on a executive function task (go/no-go) was also shown to be enhanced with tDCS in adults with MDD (Boggio et al., 2006a). tDCS has been evaluated in subjects with Parkinson's disease and found to have therapeutics benefit (compared with inactive treatment) on the Unified Parkinson's Disease Rating Scale and neuropsychological measures (reaction time, pegboard task) as well as motor evoked potentials (Fregni et al., 2006c).
Several recent studies have affirmed the safety of tDCS. Iyer and colleagues (2005) showed that, in a sample of 103 subjects, no one asked for the tDCS procedure to be stopped due to discomfort. Gandiga and colleagues (2006) compared sham to active tDCS and showed no differences in self-report ratings of discomfort. Nitsche and colleagues (2004) performed structural MRI scans on healthy individuals who underwent 1 hour exposures to tDCS; they found no evidence of structural change in the brain or alterations in blood-brain barrier permeability.
With regard to persistent challenges in the management of MDD, individuals with depression have shown cognitive deficits, particularly in working memory and other frontal lobe functions (Dunkin et al., 2000; Sweeney et al., 2000 Jaeger et al., 2006; Rose and Ebmeier 2006; Rose et al., 2006) and declarative memory (e.g., Beaden et al., 2006). By improving cognitive function in subjects with cognitive complaints that persist despite pharmacotherapy, it may be possible to improve the completeness of recovery from depression and reduce any functional disability (Jaeger et al., 2006).
There are no published reports yet of the effects of tDCS on brain function in subjects with MDD. Cordance is a quantitative electroencephalography (QEEG) measure which allows for non-invasive measurement of regional brain function (Leuchter et al., 1994a, 1994b, 1999; Cook et al., 1998). It is sensitive to changes in brain function in subjects who are responding to treatment for MDD (Cook and Leuchter 2001; Cook et al., 2002, 2005; Leuchter et al., 2002) and is being evaluated for use a a biomarker which predicts treatment outcome in MDD (NIMH Project R01MH069217, Cook PI). It is well suited to evaluating brain function in subjects with MDD during a clinical trial experiment.
Our hypotheses are
- Subjects who are randomized to receive active tDCS treatments will show greater improvement in cognitive task performance than subjects who receive inactive treatments.
- Subjects who are randomized to receive active tDCS treatments will show greater improvement in depression symptom severity scores than subjects who receive inactive treatments.
- Subjects who are randomized to receive active tDCS treatments will show greater changes in prefrontal brain function, as assessed with quantitative EEG cordance, than subjects who receive inactive treatments.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00760097
|United States, California|
|UCLA Semel Institute for Neuroscience|
|Los Angeles, California, United States, 90024|
|Principal Investigator:||Ian Cook, Dr.||University of California, Los Angeles|