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

NCT07745140 | Not Yet Recruiting

• 1 other identifier: P0048824
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Schizophrenia; Cognitive Functions

Outcome Measures

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.

  Baseline and after the 6-week interventions

Secondary Outcomes (10)

• Rapid Visual Information Processing (RVP)

  Baseline and after the 6-week interventions

• Digit Span (DGS)

  Baseline and after the 6-week interventions

• The Verbal Fluency Test (VFT)

  Baseline and after the 6-week interventions

• 6-Minute Walking Test

  Baseline and after the 6-week interventions

• The Fatigue Assessment Scale (FAS)

  Baseline and after the 6-week interventions

Study Arms (3)

Active tDCS and aerobic exercise

ACTIVE COMPARATOR

Behavioral: Aerobic exercise; Device: Active tDCS

Sham tDCS and aerobic exercise

SHAM COMPARATOR

Behavioral: Aerobic exercise; Device: Sham tDCS

Waitlist control group

NO INTERVENTION

Interventions

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 and aerobic exercise; Sham tDCS and aerobic exercise

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.

Active tDCS and aerobic exercise

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.

Sham tDCS and aerobic exercise

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hung Hom, Kowloon, Hong Kong

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Prof. Jessie LIN

CONTACT

+852 2766 6718; jx-jessie.lin@polyu.edu.hk

Study Design

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

Study Record Dates

• First Submitted: July 30, 2026
• First Posted: August 4, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)