High-definition Transcranial Direct Current Stimulation (HD-tDCS) in Late-life Depression (LLD)

NCT05322863 | Unknown

• 1 other identifier: 20191119
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the efficacy of a 2-week daily programme (10 sessions) of HD-tDCS to augment antidepressant therapy in subjects with late-life depression who had residual depressive symptoms despite adequate dosage and duration of antidepressant therapy.

Conditions

Depression in Old Age

Keywords

augmentation therapy; late-life depression

Outcome Measures

Primary Outcomes (1)

• Change in the Depressive symptoms

  the clinical response rate and the remission rate as measured with the HAM-D-17. A clinical response will be defined as a reduction of 50% or more in the HAM-D-17 score. A HAM-D-17 score of 7 or less will be used as an indicator of remission. Scores range from 0 to 52, with higher scores indicating more severe depression.

  Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.

Secondary Outcomes (8)

• Change in the Global Cognition

  Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.

• Change in the Working Memory

  Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.

• Change in the Executive Functioning

  Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.

• Change in the Verbal Fluency

  Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.

• Change in the Attention

  Assessed at baseline, immediately after the intervention, and 4 and 12 weeks after the intervention.

Study Arms (2)

active HD-tDCS

ACTIVE COMPARATOR

The participants will be instructed to relax during the first 5 minutes of the session while the equipment is set up. A mild stimulation (with a level of only 2 milliamps stimulation) will be delivered for 20 minutes, with the current gradually increased and decreased over 30 seconds. The patients will be instructed to relax and remain motionless during the intervention. The administrator will closely monitor the impedance throughout each session and record any side effects experienced by the participants. The participants will be allowed 5 minutes of rest after the intervention and will be actively asked about any discomfort. Each session will last around 30 minutes, with a total of 10 sessions (two consecutive weeks of treatment for 5 days per week).

Device: High-definition Transcranial Direct Current Stimulation

sham-HD-tDCS

SHAM COMPARATOR

The procedure for sham stimulation will be identical, except that the current will be gradually ramped down to zero after the first 30 s, thus giving the same initial sensation of HD-tDCS. The stimulator will be programmed to switch the current on and off, so no intervention by the operator will be required. The computer will be placed behind the subjects' heads so they cannot see the readout.

Device: High-definition Transcranial Direct Current Stimulation

Interventions

High-definition Transcranial Direct Current Stimulation DEVICE

The HD-tDCS will be administered by the program device called Starstim (Neuroelectrics). All participants will receive the treatment by using the same model of device. The HD-tDCS device can be portable and controlled wirelessly via computer software developed by the manufacturer. The montages will be a '4 × 1 ring set-up', which is the most commonly used HD-tDCS setting. The centre anode electrode is surrounded by four return cathode electrodes. The anode will be placed over the left dorsal lateral prefrontal cortex. Conductive electrode gel will be applied on the scalp at all designated electrode stimulation areas. A cap appropriate for each participants' head size will be used to ensure that the electrodes are secured in place. Impedance checks will be performed using the Starstim software before each treatment session.

active HD-tDCS; sham-HD-tDCS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or above
• Right-handedness, as determined by the Edinburgh Handedness Inventory (to homogenise neuroanatomical targeting)
• Chinese ethnicity
• Fulfil the criteria of Major Depressive Disorder (single or recurrent episode) and in partial remission, defined by the 5th Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
• Presence of mild to severe level of depressive symptoms measured and defined by HAM-D-17 score ≥8 and ≤ 52\[22\]
• Suboptimal treatment response with at least one adequate antidepressant trial defined as full or best tolerated doses at least 6 weeks
• Stable dosage of antidepressants or other treatments for depression in recent 4 weeks
• Valid informed written consent

You may not qualify if:

• A DSM-5 diagnosis other than Depressive Disorders (e.g., bipolar and related disorders, schizophrenia spectrum and other psychotic disorders).
• A Hong Kong Chinese version of the Montreal Cognitive Assessment (HK-MoCA) score below the second percentile according to the subject's age and education level (to exclude subjects with existing dementia)
• Alcohol or substance dependence
• Active suicidal ideation or a suicide attempt within the past month
• Concomitant unstable medical condition or major neurological conditions
• Significant communication impairment

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Department of Psychiatry, University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (25)

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  PMID: 36307858 DERIVED

Study Officials

• Pak Wing Calvin Cheng

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pak Wing Calvin Cheng

CONTACT

22554486; chengpsy@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: April 12, 2022
• Study Start: February 22, 2021
• Primary Completion: February 22, 2023
• Study Completion: February 22, 2024
• Last Updated: April 12, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)