The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorThe Hong Kong Polytechnic University

About this trial

The study will investigate the (1) additive and synergistic effects of tDCS and aerobic exercise on cognitive function and clinical symptoms in schizophrenia, and (2) neurophysiological mechanisms (mediators) underlying these effects.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Schizophrenia spectrum disorders;

Aged from 18 to 65.

Chinese-speaking (to enable cognitive testing).

Ability to understand the nature of the study and to give informed consent.

Disqualifiers

Severe physical illness (Myocardial Infarction, Hypertension, Fracture, Spinal problems in which exercise with mild-to-moderate intensity may be contraindicated).

Comorbid diagnoses of organic brain syndrome, substance misuse, history of epilepsy or seizure, intellectual disability, significant head trauma, active suicidal ideation or self-harm behaviors.

Known pregnancy, or other contraindication to tDCS or MRI (e.g., have a cardiac/heart pacemaker, brain aneurysm clips, any implanted metallic or electrical device, or any internal metal foreign objects).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aerobic exercise

    Behavioral

    Aerobic exercise training will be conducted twice per week, over a period of 6 weeks, supervised by a well-trained facilitator. Each 45-minute session consists of a warm-up (10 minutes), treadmill walking (15 minutes), stationary bike cycling (15 minutes), and cool-down stretching (5 minutes). Heart rate will be monitored throughout training by a wearable device, and 60% of the maximum heart rate (roughly calculated by 220-age) should be maintained for at least 20 minutes during each session. Participants may stop exercising at any time if they feel uncomfortable.

  • Active tDCS

    Device

    Active tDCS will be applied using a wearable stimulator (Liftid) at a constant stimulation intensity of 1.2 mA for 20 minutes. The device has been designed for anodal stimulation targeting the dorsolateral prefrontal cortex (DLPFC) using the F3 (anode) to F4 (cathode) montages.

  • Sham tDCS

    Device

    Sham tDCS will be performed using the same device but without stimulation. During the aerobic exercise training, all participants will wear the device, and a facilitator will turn on the stimulation for participants receiving a-tDCS+AE intervention, and pretend to turn on the stimulation for participants receiving s-tDCS+AE intervention after the first 10-minute warm-up section.

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Active tDCS and aerobic exerciseActive comparator 2 interventions
Group B: Sham tDCS and aerobic exerciseSham comparator 2 interventions
Group C: Waitlist control groupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Hong Kong List Learning Test (HKLLT)

A Chinese verbal memory test designed to assess the processes and organizational strategies involved in learning verbal information. The test consists of two different 16-item two-character Chinese word lists, namely the random and blocked conditions. Total learning score, short-term, and long-term memory will be recorded in both conditions.

Time frame
Baseline and after the 6-week interventions

Secondary outcomes

1

Rapid Visual Information Processing (RVP)

A measure of sustained attention. A white box is shown in the center of the screen, inside which digits from 2 to 9 appear in a pseudo-random order, at the rate of 100 digits per minute. Participants are requested to detect target sequences of digits (for example, 2-4-6, 3-5-7, 4-6-8). When the participant sees the target sequence, they must respond by selecting the button in the center of the screen as quickly as possible. The level of difficulty varies depending on whether the participant must watch for one- or three-target sequences at the same time.

Time frame
Baseline and after the 6-week interventions
2

Digit Span (DGS)

A measure of verbal short-term and working memory. The participant will hear a sequence of digits and will immediately be prompted to verbally repeat it. If the participant responds correctly, the next trial presents a longer sequence. The task terminates when participants respond incorrectly on three occasions at a span length.

Time frame
Baseline and after the 6-week interventions
3

The Verbal Fluency Test (VFT)

A measure of executive function. Participants have to name as many animals as possible in 60 seconds.

Time frame
Baseline and after the 6-week interventions
4

6-Minute Walking Test

A sub-maximal exercise test to assess the aerobic capacity and endurance. The subject has to walk as far as possible along a track for 6 minutes.

Time frame
Baseline and after the 6-week interventions

Other outcomes

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