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The Effects of tDCS on Depressive Symptoms,Neurocognitive Function and HRV in Unipolar Depression and Bipolar Depression

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03287037
Recruitment Status : Completed
First Posted : September 19, 2017
Last Update Posted : September 30, 2019
Sponsor:
Information provided by (Responsible Party):
Hsin-An Chang, MD, Tri-Service General Hospital

Study Description
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Brief Summary:
The study aimed to investigate whether transcranial direct current stimulation could improve depressive symptoms, neurocognitive function and modulate heart rate variability in unipolar and bipolar depression.

Condition or disease Intervention/treatment Phase
Depressive Disorder, Major Depression, Bipolar Electricity; Effects Device: tDCS over DLPFC Not Applicable

Detailed Description:

Background

Transcranial direct current stimulation encompasses the induction of a relatively weak constant current flow through the cerebral cortex via scalp electrodes . Dependent on stimulation polarity, this results in a modulation of cortical excitability and spontaneous neural activity. The technique was established in the 1950s and 1960s primarily in animals. In these early studies it was shown that subthreshold DC stimulation increases spontaneous neuronal activity if the anode is placed above or within the cortex, while exposure to cathodal polarity results in reduced activity. This is caused by a subthreshold membrane depolarization by anodal and a hyperpolarization by cathodal stimulation. It was demonstrated in humans that the after-effects of tDCS depend on modifications of NMDA receptor-efficacy. The after-effects of tDCS are blocked by the NMDA receptor antagonist dextromethorphan, and prolonged by the partial NMDA receptor-agonist D-cycloserine. This tDCS polarity-dependent alteration of NMDA receptor function seems to be initiated by the respective membrane potential shift and probably by the accompanying cortical activity modification,because it is prevented by the sodium channel blocker carbamazepine. Intraneuronal calcium concentration also contributes, because calcium channel antagonists eliminate the excitability-enhancing after-effects of anodal tDCS. Recently, tDCS has been reported to be a novel, non-invasive and safe therapeutic tool to treat neuropsychiatric disorders including depression. This therapeutic tool has been reported to show promising effect in treating unipolar and bipolar depression. However, the sample sizes have been small. Further work is needed to see if these early promising studies replicate. Much evidence has indicated that patients with depression show hypoactivity over left dorsolateral prefrontal cortex (DLPFC) and hyperactivity over right DLPFC. We therefore hypothesize that tDCS over DLPFC with anode placed at left DLPFC and cathode placed at right DLPFC would reduce depressive symptoms in patients with unipolar depression and bipolar depression.

The study aimed to investigate whether tDCS over DLPFC could modify depressive symptoms, neurocognitive function and heart rate variability of unipolar and bipolar depression.

Study design: open-label study.

Participants: 60 patients with unipolar depression and 60 with bipolar depression.

Others: see Arms and Interventions, Eligibility Criteria or Outcome Measures.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Sixty patients with unipolar depression (major depressive disorder) and 60 with bipolar depression were treated with 10 sessions of tDCS.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Investigate the Effect of Transcranial Direct Current Stimulation (tDCS) on Depressive Symptoms, Neurocognitive Function and Heart Rate Variability in Unipolar Depression and Bipolar Depression
Actual Study Start Date : October 2016
Actual Primary Completion Date : September 6, 2019
Actual Study Completion Date : September 6, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: tDCS over DLPFC
Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www. neuroconn.de/dc-stimulator_plus_en/) was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2). The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4. Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays. The twice daily sessions were separated by at least 3 hours.
 Device: tDCS over DLPFC
We applied tDCS over dorsolateral prefrontal cortex (DLPFC) for these depressed patients. Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www. neuroconn.de/dc-stimulator_plus_en/) was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2). The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4. Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays. The twice daily sessions were separated by at least 3 hours. All patients were maintained on their treatment throughout the study period.


Outcome Measures
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Primary Outcome Measures :
  1. Changes from baseline score of Hamilton Depression Rating Scale (HAM-D) at the timepoint immediately after tDCS, at one week and one month after tDCS [ Time Frame: One month ]
    Depression severity


Secondary Outcome Measures :
  1. Changes from baseline score of Young Mania Rating Scale (YMRS) at the timepoint immediately after tDCS, at one week and one month after tDCS [ Time Frame: One month ]
    Hypomania/mania severity

  2. Changes from baseline score of Hamilton Anxiety Rating Scale (HAM-A) at the timepoint immediately after tDCS, at one week and one month after tDCS [ Time Frame: One month ]
    Anxiety severity.

  3. Changes from basline heart rate variability (HRV) at the timepoint immediately after tDCS, at one week and one month after tDCS [ Time Frame: One month ]
    Index of autonomic functioning.

  4. Changes from baseline results of continuous performance test (CPT) at the timepoint immediately after tDCS, at one week and one month after tDCS [ Time Frame: One month ]
    Performance of prefrontal-mediated task.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who met DSM-IV-TR criteria for major depressive disorder and bipolar depression and had moderate to severe depression severity (HAM-D score more than 17) were included in the study.

Exclusion Criteria:

  1. pregnancy or breastfeeding.
  2. having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence.
  3. having contraindications for transcranial electrical/magnetic stimulation.
  4. having intracranial metal foreign bodies.
  5. having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03287037


Locations
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Taiwan
Tri-service general hospital
Taipei, Taiwan, 114
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Hsin-An Chang, M.D. Tri-Service General Hospital, National Defense Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hsin-An Chang, MD, Head of Laboratory of Psychophysiology, Department of Psychiatry, Principal Investigator, Attending Psychiatrist, Assistant Professor, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03287037    
Other Study ID Numbers: 2-103-03-002-1
First Posted: September 19, 2017    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hsin-An Chang, MD, Tri-Service General Hospital:
Unipolar depression
bipolar depression
Transcranial direct current stimulation
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Bipolar Disorder
Depressive Disorder, Major
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Bipolar and Related Disorders