SchizophreniaNCT06494124
Efficacy and Safety of tACS vs tDCS in Schizophrenia
A study testing transcranial Alternating current stimulation (tACS) and transcranial Direct current stimulation (tDCS) in people with Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial summary
This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- transcranial Alternating current stimulation (tACS) and transcranial Direct current stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIndia
- Study dates
- 3 Apr 2024to Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years
- Moderate-severe symptoms (PANSS score > 75 and/or CGI-SCH score>4) [24]
- On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment)
- Both sexes; Age range: 18-60 years
- Right-handed
- Written informed consent by the patient
Who cannot join
- Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
- Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp / head
- Co-morbid neurological disease
- Left Handed
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
All India Institute of Medical Scinces - Bhubaneswar
Bhubaneswar, Odisha, 751019
Biswa R Mishra, MD, DPM, 09438884220, brm1678@gmail.com
Debadatta Mohapatra, MD, 09438884221, psych_debadatta@aiimsbhubaneswar.edu.in
About this study
Official title: Comparison of Efficacy and Safety of Transcranial Alternating Current Stimulation vs Transcranial Direct Current Stimulation on Psychopathology Measures and Neurocognition in Chronic Schizophrenia: A Randomized Double-blind Controlled Trial
This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia.
The main question it aims to answer is:
Read more
- In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia?
Participants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).
Read the detailed description
The proposed double-blind RCT will be conducted over 3 years involving 2 centres among patients with chronic schizophrenia (moderate-severe symptoms) of either gender, aged between 18 and 60. Those with any psychiatric emergency or contraindications for tDCS will be excluded. At baseline, PANSS will be administered to assess the severity of symptom dimension, AHRS for auditory hallucinations, B-CATS for neurocognitive deficits and GAF for global functionality. Patients will be randomized equally to 3 treatment groups: tACS, tDCS, or sham stimulation (30 in each group). The intervention will involve Cathodal stimulation of left TPJ and Anodal stimulation of left DLPFC. The transcranial brain stimulations: tACS, tDCS, or sham stimulation, will be given 2 sessions per day for 10 days. Following the 5th day and after the last treatment session, PANSS, AHRS, B-CATS, and GAF will be readministered to observe for the changes in the various outcome parameters. Any new treatment-emergent serious adverse effect will be recorded.
- Conditions
- Schizophrenia
- Being tested
- transcranial Alternating current stimulation (tACS), transcranial Direct current stimulation (tDCS), Sham controlled
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial Alternating current stimulation (tACS)Device
It is a non-invasive brain stimulation technique that uses small, pulsed alternating current (1mA) to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders.
transcranial Direct current stimulation (tDCS)Device
It is a non-invasive brain stimulation technique that uses constant, low direct current to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders.
Sham controlledDevice
1mA current will be applied for the first 30 seconds to provide the initial sensation of real stimulation, and then the current will be stopped, thus minimizing the stimulatory effects. It is known to have no effect on psychopathology/neuro-cognition and means to mimic the tDCS/tACS (in order to help blinding of the participants).
| Study group | Role | What they receive |
|---|---|---|
| tACS group | Experimental | 10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current Receives: Device: transcranial Alternating current stimulation (tACS) |
| tDCS group | Active comparator | tDCS stimulation: 2 mA stimulation will be applied for 20 minutes Receives: Device: transcranial Direct current stimulation (tDCS) |
| sham controlled group | Sham comparator | 1mA current will be applied for the first 30 seconds, to provide the initial sensation of real stimulation and then the current will be stopped, thus minimizing the stimulatory effects Receives: Device: Sham controlled |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Syndrome Scale (PANSS)
Measures psychopathology and illness severity in schizophrenia
Measured: Baseline, Day 5, Day 10
Secondary outcomes (3)
Auditory Hallucination Rating Scale (AHRS)
Measures severity of auditory hallucinations in schizophrenia
Measured: Baseline, Day 5, Day 10
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Measures neurocognitive deficits in schizophrenia
Measured: Baseline, Day 5, Day 10
Global Assessment of Functioning (GAF)
Measures overall functioning of the patients with mental illness including schizophrenia
Measured: Baseline, Day 5, Day 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2024
- Study start3 Apr 2024
- Primary completionApr 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The intervention arms are Experimental (tACS), Active comparator (tDCS) and control comparator (sham). The patients in all 3 arms will continue to receive the ongoing antipsychotics.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Council of Medical Research
- Responsible party
- Principal investigator, BISWA RANJAN MISHRA, All India Institute of Medical Sciences, Bhubaneswar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06494124
- Sponsor's protocol ID
- T/EMF/Psych/21/67
- Status last verified
- Jul 2024
- First submitted
- 3 Apr 2024
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Transcranial Alternating Current Stimulation vs Transcranial Direct Current Stimulation on Psychopathology Measures and Neurocognition in Chronic Schizophrenia: A Randomized Double-blind Controlled Trial
- ClinicalTrials.gov ID
- NCT06494124
- Acronym / sponsor ID
- T/EMF/Psych/21/67
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- All India Institute of Medical Sciences, BhubaneswarUniversity, hospital or other
- Collaborators
- Indian Council of Medical Research
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 10 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical trial aims to compare the efficacy and safety of transcranial Alternating current stimulation (tACS) vs. transcranial Direct current stimulation (tDCS) vs. sham stimulation in chronic schizophrenia.
The main question it aims to answer is:
- In comparison to tDCS, can tACS improve the clinical outcome of patients with chronic schizophrenia?
Participants will be randomised into 3 groups receiving either tDCS, tACS or sham stimulation and changes in psychopathology and neuro-cognition with the interventions will be compared within and between the groups. The primary outcome measure is the Positive and Negative Syndrome Scale (PANSS), while secondary outcome measures are the Auditory Hallucination Rating Scale (AHRS), Brief Cognitive Assessment Tool for Schizophrenia (B-CATS), and Global Assessment of Functioning (GAF).
Detailed description
The proposed double-blind RCT will be conducted over 3 years involving 2 centres among patients with chronic schizophrenia (moderate-severe symptoms) of either gender, aged between 18 and 60. Those with any psychiatric emergency or contraindications for tDCS will be excluded. At baseline, PANSS will be administered to assess the severity of symptom dimension, AHRS for auditory hallucinations, B-CATS for neurocognitive deficits and GAF for global functionality. Patients will be randomized equally to 3 treatment groups: tACS, tDCS, or sham stimulation (30 in each group). The intervention will involve Cathodal stimulation of left TPJ and Anodal stimulation of left DLPFC. The transcranial brain stimulations: tACS, tDCS, or sham stimulation, will be given 2 sessions per day for 10 days. Following the 5th day and after the last treatment session, PANSS, AHRS, B-CATS, and GAF will be readministered to observe for the changes in the various outcome parameters. Any new treatment-emergent serious adverse effect will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The intervention arms are Experimental (tACS), Active comparator (tDCS) and control comparator (sham). The patients in all 3 arms will continue to receive the ongoing antipsychotics.
| Arm | Type | Receives |
|---|---|---|
| tACS group | Experimental | Device: transcranial Alternating current stimulation (tACS)10 Hz 2 mA peak-to-peak stimulation will be for 20 minutes, at zero-degree phase difference and zero offset current |
| tDCS group | Active comparator | Device: transcranial Direct current stimulation (tDCS)tDCS stimulation: 2 mA stimulation will be applied for 20 minutes |
| sham controlled group | Sham comparator | Device: Sham controlled1mA current will be applied for the first 30 seconds, to provide the initial sensation of real stimulation and then the current will be stopped, thus minimizing the stimulatory effects |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Diagnosis of Schizophrenia as per ICD-10 DCR for more than 2 years
- Moderate-severe symptoms (PANSS score > 75 and/or CGI-SCH score>4) [24]
- On stable dosing of antipsychotic medications (no changes in medication or doses for 1 month prior to enrolment)
- Both sexes; Age range: 18-60 years
- Right-handed
Key exclusion criteria (4 listed)
- Features suggestive of psychiatric emergency (for example: suicidal risk, catatonia, prolonged nutritional deprivation) or others (for example: aggression or excitement)
- Any contraindication to tDCS procedure: Metal in the head, Implanted brain medical devices, Local lesion or injury in the scalp / head
- Co-morbid neurological disease
- Left Handed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial Alternating current stimulation (tACS)It is a non-invasive brain stimulation technique that uses small, pulsed alternating current (1mA) to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders. | Device | tACS group |
| transcranial Direct current stimulation (tDCS)It is a non-invasive brain stimulation technique that uses constant, low direct current to modulate lasting cortical excitability, producing facilitatory or inhibitory effects upon a variety of behaviours, with proven efficacy in various neuropsychiatric disorders. | Device | tDCS group |
| Sham controlled1mA current will be applied for the first 30 seconds to provide the initial sensation of real stimulation, and then the current will be stopped, thus minimizing the stimulatory effects. It is known to have no effect on psychopathology/neuro-cognition and means to mimic the tDCS/tACS (in order to help blinding of the participants). | Device | sham controlled group |
Primary outcome
Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, Day 5, Day 10
Measures psychopathology and illness severity in schizophrenia
3 secondary outcomes
Auditory Hallucination Rating Scale (AHRS)
Time frame: Baseline, Day 5, Day 10
Brief Cognitive Assessment Tool for Schizophrenia (B-CATS)
Time frame: Baseline, Day 5, Day 10
Global Assessment of Functioning (GAF)
Time frame: Baseline, Day 5, Day 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial Alternating current stimulation (tACS) and transcranial Direct current stimulation (tDCS) in people with Schizophrenia, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Biswa R Mishra (09438884220, brm1678@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline, Day 5, Day 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2024.