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Not yet recruiting NCT07745140

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

No phase Interventional Schizophrenia Cognitive Functions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aerobic exercise, Active tDCS, Sham tDCS.
Who it may be relevant to
Registry conditions: Schizophrenia, Cognitive Functions. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled Trial

Overview

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.

Interventions

  • Behavioral Aerobic exercise
    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. Pa
  • Device Active tDCS
    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.
  • Device Sham tDCS
    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.

Primary outcome measures

  • Hong Kong List Learning Test (HKLLT) [Time frame: Baseline and after the 6-week interventions]
Secondary outcome measures (10)
  • Rapid Visual Information Processing (RVP) [Time frame: Baseline and after the 6-week interventions]
  • Digit Span (DGS) [Time frame: Baseline and after the 6-week interventions]
  • The Verbal Fluency Test (VFT) [Time frame: Baseline and after the 6-week interventions]
  • 6-Minute Walking Test [Time frame: Baseline and after the 6-week interventions]
  • The Fatigue Assessment Scale (FAS) [Time frame: Baseline and after the 6-week interventions]
  • The sit-and-reach test [Time frame: Baseline and after the 6-week interventions]
  • Standing Balance Test [Time frame: Baseline and after the 6-week interventions]
  • Positive and Negative Syndrome Scale (PANSS) [Time frame: Baseline and after the 6-week interventions]
  • Calgary Depression Scale (CDS) [Time frame: Baseline and after the 6-week interventions]
  • Magnetic Resonance Imaging (MRI) [Time frame: Baseline and after the 6-week interventions]

Eligibility criteria

Inclusion criteria

  • 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.
  • Fewer than 10 hours of physical exercise in the previous 3 months.

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Hong Kong Polytechnic University — Hung Hom

Identifiers

NCT: NCT07745140 · P0048824

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗