RCT of tDCS Combined With Cognitive Training in Schizophrenia

NCT04870996 | Completed DMC

• 1 other identifier: CRE-2019.239
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Given the superior effects of CT augmented tDCS in healthy subjects, the aim of the current study was to examine whether the effect of CT on cognition can be enhanced with concurrent anodal tDCS in schizophrenia patients. A double-blinded randomised controlled trial design was utilised and cognitive performances were examined at baseline (T0), immediately after the intervention (T1) and one month post-intervention (T2). It was hypothesized that concurrent CT with tDCS would result in greater and more sustainable cognitive improvement than CT alone because of increased susceptibility to neuroplasticity changes of the underlying activated network (Bikson et al., 2013; Orlov, O'Daly, et al., 2017). The effects of concurrent CT with tDCS were also assessed using blinded assessments of psychotic, negative symptoms, affective symptoms, psychosocial functioning, subjective quality of life (QOL) and tolerability in the two groups.

Conditions

Schizophrenia

Keywords

cognitive training; transcranial direct current stimulation; cognitive intervention; cognitive dysfunction; schizophrenia

Outcome Measures

Primary Outcomes (3)

• Cambridge Neuropsychological Test Automated Battery

  After a first touch screen adaption period, the participants performed four CANTAB tasks always in the same order: Reaction Time (RTI - Simple and Five choice Tone), Paired Associates Learning (PAL - Recommended Standard), Spatial Working Memory (SWM - Recommended Standard 2.0) and Rapid Visual Information Processing (RVP).The key variables from each CANTAB task were selected as the a priori primary measures.

  Score change baseline versus post-intervention versus week 4

• Trail Making Test, Part A

  Part of the MCCB measure and has a brief administration time, high tolerability, good test-retest reliability and potential changeability in response to pharmacological agents (Nuechterlein et al., 2008).

  Score change baseline versus post-intervention versus week 4

• Backward Digit Span

  The test was administered according to the instructions provided in the WAIS-IV-HK administration manual. A list of digits at a rate of one per second was read aloud, and the list was repeated in the reverse order to presentation order. All digits must be in the correct order for the list to be marked correct. The list started at a length of two digits, and two lists of each length were read aloud. The maximum span length correctly recalled was selected as the primary measure of the maximum capacity of the participant's working memory.

  Score change baseline versus post-intervention versus week 4

Secondary Outcomes (8)

• Positive and Negative Syndrome Scale

  Score change baseline versus post-intervention versus week 4

• Calgary Depression Scale for Schizophrenia (CDSS)

  Score change baseline versus post-intervention versus week 4

• Clinical Global Impression Scale

  Score change baseline versus post-intervention versus week 4

• Social and Occupational Functioning Assessment scale (SOFAS)

  Score change baseline versus post-intervention versus week 4

• World Health Organization Five Well-Being Index (WHO-5)

  Score change baseline versus post-intervention versus week 4

Study Arms (2)

Active transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT)

EXPERIMENTAL

Twenty-three participants received five treatment sessions of concurrent active tDCS and CT on five consecutive days. The participants received a ramp-up of 30 seconds, followed by active stimulation with a steady current of two milliamps for 20 minutes, then a ramp-down of 30 seconds.

Device: tDCS; Behavioral: Cognitive Training

Sham transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT)

SHAM COMPARATOR

Twenty-three participants received five treatment sessions of concurrent sham tDCS and CT on five consecutive days. The current was only delivered in the 30-second ramp-up and 30-second ramp-down periods.

Device: tDCS; Behavioral: Cognitive Training

Interventions

tDCS DEVICE

tDCS was applied using the StarStim 8 (NeuroElectrics, Barcelona, Spain). tDCS with strength of two milliamps for 20 minutes was applied based on montage recommended (Hoy et al., 2014). The stimulation electrode was applied according to international EEG system 10-20. The anode was applied at the left dorsolateral prefrontal cortexDLPFC, which was located at F3; the cathode was applied at the right dorsolateral prefrontal cortexDLPFC, which was located at F4. In the tDCS group, the participants received 'ramp-up' of 30 seconds, followed by active stimulation with a steady current of two milliamps for 20 minutes, then 'ramp-down' of 30 seconds. In the sham group, the current was only delivered in the 30-second 'ramp-up' and 30-second 'ramp-down' period.

Also known as: StarStim 8

Active transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT); Sham transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT)

Cognitive Training BEHAVIORAL

All participants received the same program of cognitive training in the app 'the Peak' on a hand-held portable iPad (https://www.peak.net/science/). The traditional Chinese version with Cantonese instructions was selected. The progress, the errors, and the sum scores were stored in the personal profile for interactive feedback on adjusting the difficulty level. The participants performed the tasks in pseudorandomized order during each session. Each training session lasted for 20 minutes, concurrent with either active or sham tDCS stimulation.

Active transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT); Sham transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT)

Eligibility Criteria

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

You may qualify if:

• Participants aged 18-65 years old; and
• Being right handed; and
• Able to communicate in Cantonese; and
• With the diagnosis of schizophrenia meeting the diagnostic criteria of the World Health Organization's 10th version of the International Statistical Classification of Disease and Related Health Problems (ICD-10). All diagnoses were ascertained at multidisciplinary team and endorsed by at least a consultant psychiatrist and a specialist in psychiatry in the clinical teams based in Tai Po Hospital.

You may not qualify if:

• Significant neurologic history such as dementia, stroke, seizure, Parkinson's disease, multiple sclerosis; or
• History of brain neurosurgery; or
• Active abuse of alcohol or illicit substances; or
• Concurrent use of cognitive-enhancing medications e.g. acetylcholinesterase inhibitors; or
• Documented history of learning disability; or
• Implanted with pacemakers, intracranial electrodes, defibrillators, metal implants in head or neck area; or
• Pregnancy or breastfeeding; or
• Changes in medication regime over the two weeks before or during the study period (Brunoni, Ferrucci, et al., 2011).

Sponsors & Collaborators

• CHAN SAU MAN, SANDRA: lead

Study Sites (1)

Department of Psychiatry, CUHK

Hong Kong, 852, Hong Kong

Location

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction

Interventions

Transcranial Direct Current Stimulation; Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Ka Ying Heidi Lo, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 22, 2021
• First Posted: May 4, 2021
• Study Start: August 23, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: May 4, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)