The Effect of Combined Brain Stimulation and Exercise for Improving Cognitive Function in Schizophrenia
30 juillet 2026 mis à jour par: LIN Jingxia Jessie, The Hong Kong Polytechnic University
Feasibility of an Integrative Treatment of Brain Stimulation and Exercise on Cognitive Function in Schizophrenia: A Pilot Randomized Controlled 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Estimé)
66
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Prof. Jessie LIN
- Numéro de téléphone: +852 2766 6718
- E-mail: jx-jessie.lin@polyu.edu.hk
Lieux d'étude
-
-
Kowloon
-
Hung Hom, Kowloon, Hong Kong
- The Hong Kong Polytechnic University
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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).
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Groupe de contrôle de la liste d'attente
|
|
|
Comparateur actif: Active tDCS and 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.
Participants may stop exercising at any time if they feel uncomfortable.
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.
|
|
Comparateur factice: Sham tDCS and 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.
Participants may stop exercising at any time if they feel uncomfortable.
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Hong Kong List Learning Test (HKLLT)
Délai: Baseline and after the 6-week interventions
|
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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Rapid Visual Information Processing (RVP)
Délai: Baseline and after the 6-week interventions
|
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.
|
Baseline and after the 6-week interventions
|
|
Digit Span (DGS)
Délai: Baseline and after the 6-week interventions
|
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.
|
Baseline and after the 6-week interventions
|
|
The Verbal Fluency Test (VFT)
Délai: Baseline and after the 6-week interventions
|
A measure of executive function.
Participants have to name as many animals as possible in 60 seconds.
|
Baseline and after the 6-week interventions
|
|
6-Minute Walking Test
Délai: Baseline and after the 6-week interventions
|
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.
|
Baseline and after the 6-week interventions
|
|
The Fatigue Assessment Scale (FAS)
Délai: Baseline and after the 6-week interventions
|
A 10-item self-report instrument that evaluates fatigue symptoms.
|
Baseline and after the 6-week interventions
|
|
The sit-and-reach test
Délai: Baseline and after the 6-week interventions
|
A common measure of flexibility, specifically assessing the lower back and hamstring muscles.
The subject is seated against the wall, arms outstretched towards the box.
A sliding ruler is used to measure the position of the fingertips.
|
Baseline and after the 6-week interventions
|
|
Standing Balance Test
Délai: Baseline and after the 6-week interventions
|
Give the subject a minute to practice their balancing before starting the test.
Then ask the person to stand on one foot for as long as possible.
The total length of time a person can stay in the balance position will be recorded.
The timing stops when the elevated foot touches the ground or the person hops or otherwise loses their balance position.
The test will be conducted with the person having their arms on their waist.
Repeat the test on the other leg.
|
Baseline and after the 6-week interventions
|
|
Positive and Negative Syndrome Scale (PANSS)
Délai: Baseline and after the 6-week interventions
|
Measuring symptom severity of patients with schizophrenia.
It contains 33 items across three subscales (Positive, Negative, and General), rated from 1-7 on each item based on clinical interviews as well as reports from family members or primary care hospital workers.
|
Baseline and after the 6-week interventions
|
|
Calgary Depression Scale (CDS)
Délai: Baseline and after the 6-week interventions
|
A 9-item scale to evaluate depression, rated from 0 to 3.
|
Baseline and after the 6-week interventions
|
|
Magnetic Resonance Imaging (MRI)
Délai: Baseline and after the 6-week interventions
|
Both structural and resting-state functional MRI will be acquired on a 3 Tesla MRI scanner (Prisma, Siemens, Germany).
For registration purposes, high-resolution T1-weighted anatomical images will be acquired during 3-D MP-RAGE (parameters: slice thickness=1mm, echo time=3.26ms,
repetition time=2250ms, inversion time=900ms, flip angle=9°, in-plane voxel size 1×1 mm2, acquisition time=5 minutes).
Functional scans (resting state) will use a gradient-echo echo-planar imaging (parameters: repetition/echo time=800/37ms; flip angle=52°; field of view=208mm; 2mm isotropic [no gap]; no. of dynamics=380, acquisition time=5 minutes).
The resting fMRI scan will be repeated for 5 times with a total acquisition time of 25 minutes.
|
Baseline and after the 6-week interventions
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 septembre 2026
Achèvement primaire (Estimé)
30 juin 2028
Achèvement de l'étude (Estimé)
31 décembre 2028
Dates d'inscription aux études
Première soumission
30 juillet 2026
Première soumission répondant aux critères de contrôle qualité
30 juillet 2026
Première publication (Réel)
4 août 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
4 août 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
30 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- P0048824
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .