SchizophreniaNCT04629352
Effect of Neuroplasticity Modulation in tDCS Treatment Response Among Schizophrenia Patients With Auditory Hallucination
A study testing Verum Accelerated Transcranial Direct Current Stimulation (acctDCS) in people with Schizophrenia and Schizoaffective Disorder, run by National Institute of Mental Health and Neuro Sciences, India at 1 site in India.
Trial summary
Schizophrenia is a severe neuropsychiatric disorder of the brain and is also one of the top ten disabling diseases. A common symptom of schizophrenia (SCZ) is hearing voices inside one's heads which others do not. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Verum Accelerated Transcranial Direct Current Stimulation (acctDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteIndia
- Study dates
- 2 Apr 2024to 31 Aug 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of schizophrenia or schizoaffective disorder as per DSM-5 (American Psychiatric Association, 2013)
- Clinically Significant Auditory Verbal Hallucinations
- Right-handedness
- Written informed consent
Who cannot join
- Features suggestive of a psychiatric emergency
- Any contraindication to tDCS procedures
- Pregnancy or post-partum status
- Left/Mixed Handedness
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Department of Psychiatry, National Institute of Mental Health And Neuro Sciences (NIMHANS), Bengaluru, Karnataka
Bengaluru, Karnataka, 560029
Anushree Bose, PhD, +91-80-26995366, anushree.cp@gmail.com
Ganesan Venkatasubramanian, MD, PhD, +91-80-26995366, gvs@nimhans.ac.in
About this study
Official title: Examining Neuroplasticity Modulation as Mechanistic Basis of tDCS Treatment Effects on Auditory Verbal Hallucination in Schizophrenia
Schizophrenia is a severe neuropsychiatric disorder of the brain and is also one of the top ten disabling diseases. A common symptom of schizophrenia (SCZ) is hearing voices inside one's heads which others do not. Despite adequate medication, SCZ patients may continue to hear voices that are often rude or unfriendly and cause distress to the patients. Transcranial direct current stimulation (tDCS) is a safe, non-invasive brain stimulation technique that reduces 'hearing voices'. However, how and why add-on tDCS works is unclear. The brain can change itself in response to its environment; this is called neuroplasticity. tDCS possibly changes the brain's environment and/or enhances the brain's ability to respond favourably to its environment. This theory will be examined here by studying changes in brain functions before and after giving tDCS to schizophrenia patients hearing voices. The aim of this study is to examine the brain's neuroplasticity potential as the biological phenomena driving treatment effects of tDCS in Schizophrenia patients with clinically significant and persistent auditory verbal hallucinations. The secondary aims are to answer whether the brain's neuroplasticity potential in schizophrenia patients can predict their responsivity to tDCS treatment for auditory verbal hallucinations, and if chronicity of illness effects tDCS treatment response.
The brain's neuroplasticity potential will be examined using neuroimaging and neurophysiological techniques that give information about the integrity of the brain's signal processing efficiency, the chemical concentration of certain bio-molecules within it, and how well different areas of the brain communicate with each other. With this information, the potential role of the brain's neuroplasticity potential in facilitating treatment effects of tDCS can be better understood. With this knowledge, it could be possible personalize tDCS treatment, profile tDCS responders and non-responders based on demographic and biological factors, and prescribe tDCS at the appropriate time within the illness course for maximal benefit to the SCZ patients.
Read the detailed description
20-30% schizophrenia (SCZ) patients struggle with auditory verbal hallucinations (AVH) minimally responsive to pharmaceutical treatments. An add-on fronto-temporoparietal transcranial direct current stimulation (tDCS) is suggested to address persistent AVH in SCZ patients. High heterogeneity among existing randomized control trials for AVH treatment in SCZ and the lack of empirical studies investigating the tDCS action mechanism warrants a systematic investigation into the mechanistic basis of tDCS action.
This proposal aims to examine the potential for neuroplasticity modulation as the mechanistic factor behind the therapeutic effects of left fronto-temporo-parietal tDCS for treating clinically significant AVH in early-course and chronic SCZ patients. It has been proposed and demonstrated that more tDCS sessions over a shorter interval lead to rapid plasticity induction. Accelerated tDCS protocol delivers a higher number of tDCS sessions over a shorter duration. Accelerated protocol (5 sessions/day for 2 days, inter-session interval~20 minutes) for the treatment of AVH in SZ showed clinical improvement with concurrent changes in neurophysiological correlates of auditory hallucination pathophysiology. Specifically, this study will examine neuroplasticity potential as a biomarker for tDCS treatment response with an accelerated tDCS (acctDCS) protocol. Using a randomized, double-blind, sham-controlled parallel-arm, pre-post design, changes in neuroplasticity potential with tDCS treatment for AVH in SCZ will be assessed. The four composite primary outcome measures of this study are:
- changes in N100-derived event-related-potential waveforms (neurophysiological),
- changes glutamine-glutamate levels (neurochemical),
- changes in resting-state functional connectivity (neuroimaging), and
- reduction in AVH severity (clinical).
The secondary objectives of this study are:
- exploring the correlation between neurobiological measures of neuroplasticity changes induced by tDCS and clinical improvement in AVH to indicate the nature and strength of the relationship between the two;
- exploring the effect of verum (active) tDCS on early course versus late course SCZ patients will uncover if illness chronicity is a potential barrier to tDCS responsivity; and
- utilizing disorder-related (age at illness onset, medication, the severity of the symptom, etc.) and biographic (age, sex, years of education, etc.) features of the study sample towards predicting neuroplasticity modulation in the study sample.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Verum Accelerated Transcranial Direct Current Stimulation (acctDCS), Sham Accelerated Transcranial Direct Current Stimulation (acctDCS)
- Keywords
- Auditory verbal hallucination, Transcranial Direct Current stimulation (tDCS), Schizophrenia, Neuroplasticity, Psychosis
- Medical subject headings
- Schizophrenia, Psychotic Disorders, Hallucinations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum Accelerated Transcranial Direct Current Stimulation (acctDCS)Device
In verum transcranial direct current stimulation (tDCS), patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For Verum-tDCS condition, 2-mA of constant current will be delivered for 20-minutes, additional ramp-up and ramp-down of 20 seconds each.
Sham Accelerated Transcranial Direct Current Stimulation (acctDCS)Device
In sham transcranial direct current stimulation (tDCS), each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. However, no current will be delivered beyond initial ramp-up time though the tDCS device display will indicate that 2mA current is being applied.
| Study group | Role | What they receive |
|---|---|---|
| Verum Accelerated Transcranial Direct Current Stimulation (acctDCS) | Experimental | Each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For the Verum-tDCS condition, 2-mA of constant current will be delivered for 20 minutes, with additional ramp-up and ramp-down of 30 seconds each. Receives: Device: Verum Accelerated Transcranial Direct Current Stimulation (acctDCS) |
| Sham Accelerated Transcranial Direct Current Stimulation (tDCS) | Placebo comparator | Each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For Sham-tDCS, no current will be delivered beyond the initial ramp-up time. Receives: Device: Sham Accelerated Transcranial Direct Current Stimulation (acctDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological Measure: Change in amplitude of N100-related waveforms
Event-related potential (N100) based indices of changes in early auditory processing and adaptive plasticity in response to tDCS treatment.
Measured: Baseline: Day-1, After single session of tDCS: Day-1, Day-6: After 10 sessions of RCT tDCS
Neuro-Chemical Measure: Change in concentration of glutamate-glutamine levels
Spectroscopy based indices of glutamate-glutamine levels at left temporo-parietal junction (TPJ) and left prefrontal cortex (PFC) in response to tDCS treatment.
Measured: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS
Neuro-haemodynamic Measure: Change in strength of resting-state-functional-connectivity among brain areas
Neuroimaging based indices of seed-based resting-state-functional-connectivity (rs-FC) of the left-TPJ with left-PFC in response to tDCS treatment.
Measured: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS
Clinical Measure: Change in auditory verbal hallucination score
Change in auditory hallucination severity as indicated by Auditory Hallucination Rating Scale (AHRS) scores. Minimum score is 2 and maximum score is 41. Higher the score more severe the symptom.
Measured: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS, One month Follow-up, Three-months follow-up
Secondary outcomes (2)
Change in auditory hallucination severity in responsive schizophrenia patients (with ≥25% reduction in auditory hallucination severity at post RCT time point) at 1-month and 3-month follow-up
Change in auditory hallucination severity as indicated by Auditory Hallucination Rating Scale at (AHRS) scores at clinical follow-up. Minimum score is 2 and maximum score is 41. Higher the score more severe the symptom.
Measured: One-month Follow-up, Three-month follow-up
Change in auditory hallucination score in early course and late course schizophrenia patients
Both Early course (illness duration ≤2 years; n=36) and Late course (illness duration ≥5 years; n=36) schizophrenia patients will be recruited to explore the influence of illness chronicity on neuroplasticity potential and tDCS responsivity. Change in auditory hallucination severity as indicated by Auditory Hallucination Rating Scale at (AHRS) scores. Minimum score is 2 and maximum score is 41. Higher the score more severe the symptom.
Measured: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study start2 Apr 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This prospective longitudinal study will administer add-on accelerated tDCS to SCZ patients in a double-blind, randomised, parallel-arm sham-controlled design. In the accelerated tDCS protocol, 10 sessions (5 sessions per day) will be administered over 2 days. Patients who show ≥20% reduction in AVH severity will be followed up at one month and three months after completion of tDCS-RCT, and other patients will be offered clinician-determined treatment, including open-label accelerated tDCS treatment.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anushree Bose, National Institute of Mental Health and Neuro Sciences, India
- Investigators
- Anushree Bose, PhD, Principal investigator, Department of Psychiatry, NIMHANS, Bengaluru, Karnataka, IndiaGanesan Venkatasubramanian, MD, PhD, Study chair, Professor at Department of Psychiatry, NIMHANS, Bengaluru, Karnataka, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629352
- Sponsor's protocol ID
- IA/CPHE/19/1/504591
- Status last verified
- May 2024
- First submitted
- 2 Nov 2020
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) that underlie the results reported in specific publication arising out of the trial will be shared with researchers for individual participant data meta-analysis.
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Neuroplasticity Modulation as Mechanistic Basis of tDCS Treatment Effects on Auditory Verbal Hallucination in Schizophrenia
- ClinicalTrials.gov ID
- NCT04629352
- Acronym / sponsor ID
- IA/CPHE/19/1/504591
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Auditory verbal hallucination, Transcranial Direct Current stimulation (tDCS), Schizophrenia, Neuroplasticity, Psychosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- National Institute of Mental Health and Neuro Sciences, IndiaUniversity, hospital or other
- Study start
- 2 Apr 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 16 Nov 2020 (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.
Schizophrenia is a severe neuropsychiatric disorder of the brain and is also one of the top ten disabling diseases. A common symptom of schizophrenia (SCZ) is hearing voices inside one's heads which others do not. Despite adequate medication, SCZ patients may continue to hear voices that are often rude or unfriendly and cause distress to the patients. Transcranial direct current stimulation (tDCS) is a safe, non-invasive brain stimulation technique that reduces 'hearing voices'. However, how and why add-on tDCS works is unclear. The brain can change itself in response to its environment; this is called neuroplasticity. tDCS possibly changes the brain's environment and/or enhances the brain's ability to respond favourably to its environment. This theory will be examined here by studying changes in brain functions before and after giving tDCS to schizophrenia patients hearing voices. The aim of this study is to examine the brain's neuroplasticity potential as the biological phenomena driving treatment effects of tDCS in Schizophrenia patients with clinically significant and persistent auditory verbal hallucinations. The secondary aims are to answer whether the brain's neuroplasticity potential in schizophrenia patients can predict their responsivity to tDCS treatment for auditory verbal hallucinations, and if chronicity of illness effects tDCS treatment response.
The brain's neuroplasticity potential will be examined using neuroimaging and neurophysiological techniques that give information about the integrity of the brain's signal processing efficiency, the chemical concentration of certain bio-molecules within it, and how well different areas of the brain communicate with each other. With this information, the potential role of the brain's neuroplasticity potential in facilitating treatment effects of tDCS can be better understood. With this knowledge, it could be possible personalize tDCS treatment, profile tDCS responders and non-responders based on demographic and biological factors, and prescribe tDCS at the appropriate time within the illness course for maximal benefit to the SCZ patients.
Detailed description
20-30% schizophrenia (SCZ) patients struggle with auditory verbal hallucinations (AVH) minimally responsive to pharmaceutical treatments. An add-on fronto-temporoparietal transcranial direct current stimulation (tDCS) is suggested to address persistent AVH in SCZ patients. High heterogeneity among existing randomized control trials for AVH treatment in SCZ and the lack of empirical studies investigating the tDCS action mechanism warrants a systematic investigation into the mechanistic basis of tDCS action.
This proposal aims to examine the potential for neuroplasticity modulation as the mechanistic factor behind the therapeutic effects of left fronto-temporo-parietal tDCS for treating clinically significant AVH in early-course and chronic SCZ patients. It has been proposed and demonstrated that more tDCS sessions over a shorter interval lead to rapid plasticity induction. Accelerated tDCS protocol delivers a higher number of tDCS sessions over a shorter duration. Accelerated protocol (5 sessions/day for 2 days, inter-session interval~20 minutes) for the treatment of AVH in SZ showed clinical improvement with concurrent changes in neurophysiological correlates of auditory hallucination pathophysiology. Specifically, this study will examine neuroplasticity potential as a biomarker for tDCS treatment response with an accelerated tDCS (acctDCS) protocol. Using a randomized, double-blind, sham-controlled parallel-arm, pre-post design, changes in neuroplasticity potential with tDCS treatment for AVH in SCZ will be assessed. The four composite primary outcome measures of this study are:
- changes in N100-derived event-related-potential waveforms (neurophysiological),
- changes glutamine-glutamate levels (neurochemical),
- changes in resting-state functional connectivity (neuroimaging), and
- reduction in AVH severity (clinical).
The secondary objectives of this study are:
- exploring the correlation between neurobiological measures of neuroplasticity changes induced by tDCS and clinical improvement in AVH to indicate the nature and strength of the relationship between the two;
- exploring the effect of verum (active) tDCS on early course versus late course SCZ patients will uncover if illness chronicity is a potential barrier to tDCS responsivity; and
- utilizing disorder-related (age at illness onset, medication, the severity of the symptom, etc.) and biographic (age, sex, years of education, etc.) features of the study sample towards predicting neuroplasticity modulation in the study sample.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This prospective longitudinal study will administer add-on accelerated tDCS to SCZ patients in a double-blind, randomised, parallel-arm sham-controlled design. In the accelerated tDCS protocol, 10 sessions (5 sessions per day) will be administered over 2 days. Patients who show ≥20% reduction in AVH severity will be followed up at one month and three months after completion of tDCS-RCT, and other patients will be offered clinician-determined treatment, including open-label accelerated tDCS treatment.
| Arm | Type | Receives |
|---|---|---|
| Verum Accelerated Transcranial Direct Current Stimulation (acctDCS) | Experimental | Device: Verum Accelerated Transcranial Direct Current Stimulation (acctDCS)Each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For the Verum-tDCS condition, 2-mA of constant current will be delivered for 20 minutes, with additional ramp-up and ramp-down of 30 seconds each. |
| Sham Accelerated Transcranial Direct Current Stimulation (tDCS) | Placebo comparator | Device: Sham Accelerated Transcranial Direct Current Stimulation (acctDCS)Each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For Sham-tDCS, no current will be delivered beyond the initial ramp-up time. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of schizophrenia or schizoaffective disorder as per DSM-5 (American Psychiatric Association, 2013)
- Clinically Significant Auditory Verbal Hallucinations
- Right-handedness
- Written informed consent
Key exclusion criteria (4 listed)
- Features suggestive of a psychiatric emergency
- Any contraindication to tDCS procedures
- Pregnancy or post-partum status
- Left/Mixed Handedness
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 |
|---|---|---|
| Verum Accelerated Transcranial Direct Current Stimulation (acctDCS)In verum transcranial direct current stimulation (tDCS), patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For Verum-tDCS condition, 2-mA of constant current will be delivered for 20-minutes, additional ramp-up and ramp-down of 20 seconds each. | Device | Verum Accelerated Transcranial Direct Current Stimulation (acctDCS) |
| Sham Accelerated Transcranial Direct Current Stimulation (acctDCS)In sham transcranial direct current stimulation (tDCS), each SCZ patient will receive five sessions daily for two days, a 10-session course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. However, no current will be delivered beyond initial ramp-up time though the tDCS device display will indicate that 2mA current is being applied. | Device | Sham Accelerated Transcranial Direct Current Stimulation (tDCS) |
Primary outcome
Neurophysiological Measure: Change in amplitude of N100-related waveforms
Time frame: Baseline: Day-1, After single session of tDCS: Day-1, Day-6: After 10 sessions of RCT tDCS
Event-related potential (N100) based indices of changes in early auditory processing and adaptive plasticity in response to tDCS treatment.
Neuro-Chemical Measure: Change in concentration of glutamate-glutamine levels
Time frame: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS
Spectroscopy based indices of glutamate-glutamine levels at left temporo-parietal junction (TPJ) and left prefrontal cortex (PFC) in response to tDCS treatment.
Neuro-haemodynamic Measure: Change in strength of resting-state-functional-connectivity among brain areas
Time frame: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS
Neuroimaging based indices of seed-based resting-state-functional-connectivity (rs-FC) of the left-TPJ with left-PFC in response to tDCS treatment.
Clinical Measure: Change in auditory verbal hallucination score
Time frame: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS, One month Follow-up, Three-months follow-up
Change in auditory hallucination severity as indicated by Auditory Hallucination Rating Scale (AHRS) scores. Minimum score is 2 and maximum score is 41. Higher the score more severe the symptom.
2 secondary outcomes
Change in auditory hallucination severity in responsive schizophrenia patients (with ≥25% reduction in auditory hallucination severity at post RCT time point) at 1-month and 3-month follow-up
Time frame: One-month Follow-up, Three-month follow-up
Change in auditory hallucination score in early course and late course schizophrenia patients
Time frame: Baseline: Day-1, Day-6: After 10 sessions of RCT tDCS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2025.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) that underlie the results reported in specific publication arising out of the trial will be shared with researchers for individual participant data meta-analysis.
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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.
Anushree Bose, PhD principal investigator
Department of Psychiatry, NIMHANS, Bengaluru, Karnataka, India
Ganesan Venkatasubramanian, MD, PhD study chair
Professor at Department of Psychiatry, NIMHANS, Bengaluru, Karnataka, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum Accelerated Transcranial Direct Current Stimulation (acctDCS) in people with Schizophrenia and Schizoaffective Disorder, run by National Institute of Mental Health and Neuro Sciences, India 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 4 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 22 May 2025. 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 Anushree Bose, PhD (+91-8026995366, anushree.cp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurophysiological Measure: Change in amplitude of N100-related waveforms (time frame: Baseline: Day-1, After single session of tDCS: Day-1, Day-6: After 10 sessions of RCT tDCS). The study lists 4 primary outcomes in all. 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 22 May 2025.