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

NCT03287037 | Completed

• 1 other identifier: 2-103-03-002-1
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Depressive Disorder, Major; Depression, Bipolar; Electricity; Effects

Keywords

Unipolar depression; bipolar depression; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (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

  Depression severity

  One month

Secondary Outcomes (4)

• Changes from baseline score of Young Mania Rating Scale (YMRS) at the timepoint immediately after tDCS, at one week and one month after tDCS

  One month

• 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

  One month

• Changes from basline heart rate variability (HRV) at the timepoint immediately after tDCS, at one week and one month after tDCS

  One month

• Changes from baseline results of continuous performance test (CPT) at the timepoint immediately after tDCS, at one week and one month after tDCS

  One month

Study Arms (1)

tDCS over DLPFC

EXPERIMENTAL

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

Interventions

tDCS over DLPFC DEVICE

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.

tDCS over DLPFC

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• pregnancy or breastfeeding.
• having epilepsy, severe physical illness, any current psychiatric comorbidity or history of substance dependence.
• having contraindications for transcranial electrical/magnetic stimulation.
• having intracranial metal foreign bodies.
• having a history of intracranial neoplasms or surgery, or a history of severe head injuries or cerebrovascular diseases.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-service general hospital

Taipei, 114, Taiwan

Location

Related Publications (1)

• Lin YY, Chang CC, Huang CC, Tzeng NS, Kao YC, Chang HA. Efficacy and neurophysiological predictors of treatment response of adjunct bifrontal transcranial direct current stimulation (tDCS) in treating unipolar and bipolar depression. J Affect Disord. 2021 Feb 1;280(Pt A):295-304. doi: 10.1016/j.jad.2020.11.030. Epub 2020 Nov 11.

  PMID: 33221715 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Bipolar Disorder; Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Bipolar and Related Disorders

Study Officials

• Hsin-An Chang, M.D.

  Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Laboratory of Psychophysiology, Department of Psychiatry, Principal Investigator, Attending Psychiatrist, Assistant Professor

Model Details: Sixty patients with unipolar depression (major depressive disorder) and 60 with bipolar depression were treated with 10 sessions of tDCS.

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 19, 2017
• Study Start: October 1, 2016
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: September 30, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)