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Giving Magnetic therapy a type of Brain Stimulation to Help People with Schizophrenia with Their Thinking and speech.

Modulating the Left - Anterior Temporal Lobe with Intermittent theta Burst Stimulation to target Language and Cognitive dysfunctions in patients with schizophrenia: An Open label Pilot study - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/03/063549
Enrollment
30
Registered
2024-03-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: F20- Schizophrenia

Interventions

Intervention1: Intermittent theta burst stimulation a type of transcranial magnetic stimulation: Intermittent theta burst stimulation (iTBS) a type of transcranial magnetic stimulation over left anter

Sponsors

Dr Pratima Murthy
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with schizophrenia with capacity to consent. 2. Age range: 18 – 45 years 3. Patients with schizophrenia exhibiting cognitive deficits, defined as BACS scores (any domain) falling 1 or more standard deviations below the mean and standard deviation derived from a local healthy population cohort. 4. Right handed individuals assessed by Edinburgh Handedness scale. 5. Having moderate level of symptoms as measured by a score of 4 or more on Global rating on any domains in SAPS or SANS scale. 6. No contraindication for MRI and TMS (as assessed by TASS checklist) 7. No risk of harm to self or harm to others 8. No active substance use in the last 3 months (apart from nicotine).

Exclusion criteria

Exclusion criteria: 1. Features suggestive of risk of harm to self (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement) 2. Unstable medical condition 3. History of uncontrolled seizures 4. Co morbid medical or neurological disorder that can affect structure of the brain. 5. Pregnancy or postpartum state 6. Comorbid substance abuse or dependence 7. Significant neurologic disorder 8. Any contraindication for MRI & TMS 9. Left/mixed Handedness

Design outcomes

Primary

MeasureTime frame
Verbal fluency Test scores.Timepoint: Time point 1 (T1)- Baseline Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for any predefined reasons)

Secondary

MeasureTime frame
1. Scale for the Assessment of Positive Symptom (SAPS) 2. Scale for the Assessment of Negative Symptom (SANS) 3. Brief Psychiatric Rating Scale (BPRS). 4. Clinical Global Impressions (CGI) Scale 5. Brief Assessment of Cognition in Schizophrenia (BACS) 6. Social and Occupational Functioning Assessment Scale (SOFAS) 7. NLP (Natural Language Processing) metrics derived from recorded speech interview. 8. Brain magnetic imaging measures (structural image, task based functional images, resting-state functional images, diffusion tensor images, glutamate levels at left anterior temporal cortex from MR spectroscopy) 9. TMS- Electroencephalography measures at Baseline. Timepoint: Time point 1 (T1)- Baseline Time point 2 (T2)- End of intervention of the study i.e End of 10th session (5DAYS) or termination of the trial for any predefined reasons)

Countries

India

Contacts

Public ContactDr Kiran Basawaraj Bagali

NIMHANS (National Institute of Mental Health and Neurosciences)

urvakhsh@gmail.com08026995805

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026