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L'essai clinique NCT06961916 pour Schizophrénie est en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)
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L'étude clinique NCT06961916 est un essai interventionnel pour Schizophrénie. Son statut actuel est : en recrutement. L'étude a débuté le 3 juin 2025 et vise à recruter 120 participants. Dirigé par The University of Texas Health Science Center, Houston, l'essai devrait être terminé d'ici le 1 mai 2029. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 5 juin 2025.
Résumé succinct
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil combined with cognitive training for improving white matter integrity.
Description détaillée
Schizophrenia is a severe mental illness that affects about 1% of the population but a major source of disability. Information processing between brain regions occurs due to transfer of electrical impulses among them. This process is determined by the existing neuronal/fiber connections, which may be altered and or modified in the presence of neuronal stimulation or cognitive intervention. The frontal lobe information flow is critical for higher cognitive functions, thought processes, and proper emotional and behavioral responses. Improving the myelination in the frontal lobe may increase cognitive functions and reduce risks to develop symptoms of schizophrenia. The investigators propose that increasing electrical signaling in the frontal white matter in patients with schizophrenia may also enhance myelination and improve the white matter integrity.
The patients with schizophrenia will receive active repetitive transcranial magnetic stimulation (rTMS) treatment combined with cognitive training. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. The efficacy of its combination with cognitive training in myelination modulation has not been evaluated.
Titre officiel
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)
Conditions
SchizophrénieAutres identifiants de l'essai
- HSC-MS-23-1044 (study 2)
Numéro NCT
Date de début (réel)
2025-06-03
Dernière mise à jour publiée
2025-06-05
Date de fin (estimée)
2029-05-01
Inscription (estimée)
120
Type d'essai
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Transcranial magnetic stimulation
schizophrenia
white matter
connectivity
myelination
schizophrenia
white matter
connectivity
myelination
Objectif principal
Traitement
Plan d'attribution
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalActive rTMS combined with Cognitive Training Participants will receive active H-coil delivered rTMS, as well as cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. | rTMS active Active H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete. Entraînement cognitif For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI) | Fractional anisotropy (FA) values will be reported. FA values range from 0 to 1 with larger values indicating greater white matter integrity. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI) | rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG) | Mismatch negativity values will be reported in microvolts (uV). Mismatch negativity is measured by subtracting the averaged response to a set of standard stimuli from the average response to deviant stimuli, and taking the amplitude of this difference in a given timepoint. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG) | Steady-state auditory evoked responses will be reported. The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies. The ration will be obtained in a given timepoint. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Cognitive insight as assessed by the Beck Cognitive Insight Scale | Total score will be reported and ranges from 15 to 60, with a higher score indicating greater cognitive insight. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Depression as assessed by the Depression State and Trait Scale (DST) - state | Total score of the state subscale of the DST will be reported and ranges from 0 to 72, with a higher score indicating greater depression state. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Depression as assessed by the Depression State and Trait Scale (DST) - trait | Total score of the trait subscale of the DST will be reported and ranges from 0 to 72, with a higher score indicating greater depression trait. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Depression as assessed by the Calgary Depression Scale | Total score of the Calgary Depression Scale will be reported and ranges from 0 to 27, with a higher score indicating greater depression. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Depression as assessed by the Beck Depression Inventory | Total score of the Beck Depression Inventory will be reported and ranges from 0 to 63, with a higher score indicating greater depression. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Perception as assessed by the Perception State and Trait Scale - state | The Perception State and Trait Scale assesses alterations in the perception of audio and visual experiences. Total score ranges from 0 to 96 for the state subscale, and a higher score indicates a greater alteration of audio or visual experiences state. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Perception as assessed by the Perception State and Trait Scale - trait | The Perception State and Trait Scale assesses alterations in the perception of audio and visual experiences. Total score ranges from 0 to 96 for the trait subscale, and a higher score indicates a greater alteration of audio or visual experiences trait. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Delusion as assessed by the 21-item Peters Delusion Inventory (PDI-21) | Total score will be reported and ranges from 0 to 21, with a higher score indicating greater delusion. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Emotion regulation as assessed by the Profile of Mood States (POMS) | Total score will be reported and ranges from 0 to 204, with a higher score indicating more positive emotion and mood. This outcome measure will be assessed at each of the 10 treatment visits (which are about day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, respectively). | day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, |
Hallucination as assessed by the Revised Hallucinations Scale (RHS) | Total score will be reported and ranges from 0 to 13, with a higher score indicating greater hallucination. This outcome measure will be assessed at each of the 10 treatment visits (which are about day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, respectively). | day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline |
Cognitive function as assessed by the Letter-Number Span subscale of the MATRICS consensus cognitive battery (MCCB) | Total score will be reported and ranges from 0 to 24, with a higher score indicating greater cognitive function. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Cognitive function as assessed by the Spatial Span subscale of the MATRICS consensus cognitive battery (MCCB) | Total score will be reported and ranges from 0 to 32, with a higher score indicating greater cognitive function. | baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) |
Critères d'éligibilité
Âges éligibles
Adulte
Âge minimum
18 Years
Sexes éligibles
Tous
- Male and female ages between ages 18-60 years
- Ability to give written informed consent (age 18 or above)
- Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
- Inability to sign informed consent.
- Any history of seizures.
- Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria).
- Taking > 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
- Failed TMS screening questionnaire.
- Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence.
- A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)
- Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test).
- History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality).
- For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.
The University of Texas Health Science Center, HoustonPartie responsable de l'essai
Xiaoming Du, Investigateur principal, Assistant Professor, The University of Texas Health Science Center, Houston
Contact central de l'essai
Contact: Bhim M Adhikari, 713-486-2740, [email protected]
Contact: Xiaoming Du, PhD, 443-882-9717, [email protected]
1 Centres de l'essai dans 1 pays
Texas
The University of Texas Health Science Center, Houston, Houston, Texas, 77054, United States
Xiaoming Du, PhD, Contact, 410-402-6036, [email protected]
Bhim Adhikari, Contact, 713-486-2740, [email protected]
En recrutement