SchizophreniaNCT04870996
RCT of tDCS Combined With Cognitive Training in Schizophrenia
A study testing tDCS and Cognitive Training in people with Schizophrenia, run by CHAN SAU MAN, SANDRA at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Schizophrenia
- What is being tested?
- tDCS and Cognitive Training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteHong Kong
- Study dates
- 23 Aug 2019to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Trial of Concurrent Cognitive Training and Transcranial Direct Current Stimulation or Cognitive Training Alone in Patients With Schizophrenia.
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.
Read the detailed description
The current study is a parallel-group, double-blinded, randomised controlled trial that aimed to fill the knowledge gap in investigating the effect of five sessions of concurrent cognitive training with 'online' tDCS on specific cognitive domains in stable schizophrenia patients at two time-points, (i) immediately after the intervention (ii) at one month after intervention.
It was hypothesized that concurrent cognitive training with 'online' tDCS would result in greater incremental effective improvements in cognitive domains as compared to the cognitive training alone, and the effect would be sustainable at one-month follow-up. The effect of the concurrent cognitive training with 'online' 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.
Participant were randomly allocated to one of the two groups using a predetermined randomisation sequence and block randomisation generator (block of 6). Group 1 received active tDCS stimulation and CT and will be referred to as the active tDCS + CT group. Group 2 received sham tDCS and CT and will be referred to as the sham tDCS + CT group. Both groups consisted of 23 participants and received five treatment sessions on five consecutive days.
Stimulation protocol with the corresponding randomisation code was set up by an independent psychiatrist.The double-blind administration panel of the SatrStim8 system of tDCS ensured effective blinding; both the principal investigator and the participants were blinded to the group allocation until the statistical analysis stage. All outcome measures were assessed at three time-points (T0, baseline; T1, end-treatment course; and T2, at one-month post-intervention).
Declaration:
The research protocol fully complies with the Declaration of Helsinki and the guidelines of ICH-GCP.
- Conditions
- Schizophrenia
- Being tested
- tDCS, Cognitive Training
- Keywords
- cognitive training, transcranial direct current stimulation, cognitive intervention, cognitive dysfunction, schizophrenia
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
Also called StarStim 8
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.
Cognitive TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: tDCS; Behavioral: Cognitive Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: Score change baseline versus post-intervention versus week 4
Secondary outcomes (8)
Positive and Negative Syndrome Scale
It is a 30-item clinician rated questionnaire to assess the symptoms in schizophrenia patient. It has three sub-categories of positive symptoms, negative symptoms and general psychopathology. It is shown to have good construct validity , internal reliability and inter-rater reliability (Lindstrom et al., 1994). It is also shown to be sensitive to change (Santor et al., 2007). Each item is rated on a 7-point scale. Minimum value is 30 and maximum value is 210. Higher score indicates more severe symptoms.
Measured: Score change baseline versus post-intervention versus week 4
Calgary Depression Scale for Schizophrenia (CDSS)
It is a nine-item clinician rated questionnaire. It is administered following a semi-structured interview. It has been used by other tDCS studies in schizophrenia, and it has been shown to be reliable, valid and sensitive to depressive symptoms separate from positive, negative and extrapyramidal symptoms in schizophrenia. A score above six has 82% specificity and 85% sensitivity for predicting the presence of a major depressive episode
Measured: Score change baseline versus post-intervention versus week 4
Clinical Global Impression Scale
It is a three-item clinician rated questionnaire to assess illness severity, global improvement or change, and treatment response. Higher scores indicate more severe pathology. The first two items can be rated from 1-7 and the third item consist of a 4×4 rating scale (1-16) that assesses the therapeutic effect of treatment and associated side effects.
Measured: Score change baseline versus post-intervention versus week 4
Social and Occupational Functioning Assessment scale (SOFAS)
It is a 100-point single-item rating scale to assess patients' personal and social functioning. A score of 0 indicates "Inadequate information". A score of 10 indicates Persistent inability to maintain minimal personal hygiene. Unable to function without harming self or others or without considerable external support (e.g., nursing care and supervision), while a score of 100 indicates superior functioning in a wide range of activities.
Measured: Score change baseline versus post-intervention versus week 4
World Health Organization Five Well-Being Index (WHO-5)
It is a five-item self-reported questionnaire of subjective quality of life.
Measured: Score change baseline versus post-intervention versus week 4
Ratings on Motivation and Enjoyment on Cognitive Training.
Visual Analog Scale to rate their motivation and enjoyment to participate in the gamified computerised cognitive training programme (scores ranged from 0-100, with higher scores indicating enhanced enjoyment/ willingness to come).
Measured: Score change baseline versus post-intervention versus week 4
An Adverse Effects Questionnaire
It is associated with tDCS administration, which has been generated from a systematic review in 2011 by Brunoni.
Measured: Score change baseline versus post-intervention versus week 4
Beck Cognitive Insight Scale Taiwanese Version
It is 15-tem self-reported questionnaire with two subscales (nine items tapping self-reflectiveness and six on self-certainty). It is shown to have Cronbach's alpha values of >0.70 for both subscales and has moderate stability.
Measured: Score change baseline versus post-intervention versus week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start23 Aug 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHAN SAU MAN, SANDRA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, CHAN SAU MAN, SANDRA, Chinese University of Hong Kong
- Investigators
- Ka Ying Heidi Lo, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04870996
- Sponsor's protocol ID
- CRE-2019.239
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As they are all clinical subjects, their data should be strictly confidential.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Concurrent Cognitive Training and Transcranial Direct Current Stimulation or Cognitive Training Alone in Patients With Schizophrenia.
- ClinicalTrials.gov ID
- NCT04870996
- Acronym / sponsor ID
- CRE-2019.239
- Conditions
- Schizophrenia
- Keywords
- cognitive training, transcranial direct current stimulation, cognitive intervention, cognitive dysfunction, schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- CHAN SAU MAN, SANDRAUniversity, hospital or other
- Study start
- 23 Aug 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The current study is a parallel-group, double-blinded, randomised controlled trial that aimed to fill the knowledge gap in investigating the effect of five sessions of concurrent cognitive training with 'online' tDCS on specific cognitive domains in stable schizophrenia patients at two time-points, (i) immediately after the intervention (ii) at one month after intervention.
It was hypothesized that concurrent cognitive training with 'online' tDCS would result in greater incremental effective improvements in cognitive domains as compared to the cognitive training alone, and the effect would be sustainable at one-month follow-up. The effect of the concurrent cognitive training with 'online' 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.
Participant were randomly allocated to one of the two groups using a predetermined randomisation sequence and block randomisation generator (block of 6). Group 1 received active tDCS stimulation and CT and will be referred to as the active tDCS + CT group. Group 2 received sham tDCS and CT and will be referred to as the sham tDCS + CT group. Both groups consisted of 23 participants and received five treatment sessions on five consecutive days.
Stimulation protocol with the corresponding randomisation code was set up by an independent psychiatrist.The double-blind administration panel of the SatrStim8 system of tDCS ensured effective blinding; both the principal investigator and the participants were blinded to the group allocation until the statistical analysis stage. All outcome measures were assessed at three time-points (T0, baseline; T1, end-treatment course; and T2, at one-month post-intervention).
Declaration:
The research protocol fully complies with the Declaration of Helsinki and the guidelines of ICH-GCP.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT) | Experimental | Device: tDCS, Behavioral: Cognitive TrainingTwenty-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. |
| Sham transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT) | Sham comparator | Device: tDCS, Behavioral: Cognitive TrainingTwenty-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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSAlso: StarStim 8tDCS 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. | Device | Active transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT), Sham transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT) |
| Cognitive TrainingAll 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. | Behavioural | Active transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT), Sham transcranial Direct Current Stimulation (tDCS) + Cognitive training (CT) |
Primary outcome
Cambridge Neuropsychological Test Automated Battery
Time frame: Score change baseline versus post-intervention versus week 4
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.
Trail Making Test, Part A
Time frame: Score change baseline versus post-intervention versus week 4
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).
Backward Digit Span
Time frame: Score change baseline versus post-intervention versus week 4
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.
8 secondary outcomes
Positive and Negative Syndrome Scale
Time frame: Score change baseline versus post-intervention versus week 4
Calgary Depression Scale for Schizophrenia (CDSS)
Time frame: Score change baseline versus post-intervention versus week 4
Clinical Global Impression Scale
Time frame: Score change baseline versus post-intervention versus week 4
Social and Occupational Functioning Assessment scale (SOFAS)
Time frame: Score change baseline versus post-intervention versus week 4
World Health Organization Five Well-Being Index (WHO-5)
Time frame: Score change baseline versus post-intervention versus week 4
Ratings on Motivation and Enjoyment on Cognitive Training.
Time frame: Score change baseline versus post-intervention versus week 4
An Adverse Effects Questionnaire
Time frame: Score change baseline versus post-intervention versus week 4
Beck Cognitive Insight Scale Taiwanese Version
Time frame: Score change baseline versus post-intervention versus week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No. As they are all clinical subjects, their data should be strictly confidential.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ka Ying Heidi Lo, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS and Cognitive Training in people with Schizophrenia, run by CHAN SAU MAN, SANDRA at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cambridge Neuropsychological Test Automated Battery (time frame: Score change baseline versus post-intervention versus week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.