Ignite Creation Date:
2024-05-06 @ 3:24 PM
Last Modification Date:
2024-10-26 @ 1:49 PM
Study NCT ID:
NCT04629352
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2020-11-02
Brief Title:
Effect of Neuroplasticity Modulation in tDCS Treatment Response Among Schizophrenia Patients With Auditory Hallucination
Sponsor:
National Institute of Mental Health and Neuro Sciences India
Organization:
National Institute of Mental Health and Neuro Sciences India
Study Overview
Official Title:
Examining Neuroplasticity Modulation as Mechanistic Basis of tDCS Treatment Effects on Auditory Verbal Hallucination in Schizophrenia
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 ones 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 brains environment andor enhances the brains 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 brains 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 brains 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 brains neuroplasticity potential will be examined using neuroimaging and neurophysiological techniques that give information about the integrity of the brains 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 brains 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
The brains neuroplasticity potential will be examined using neuroimaging and neurophysiological techniques that give information about the integrity of the brains 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 brains 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 sessionsday for 2 days inter-session interval20 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
1 changes in N100-derived event-related-potential waveforms neurophysiological
2 changes glutamine-glutamate levels neurochemical
3 changes in resting-state functional connectivity neuroimaging and
4 reduction in AVH severity clinical
The secondary objectives of this study are
1 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
2 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
3 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
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 sessionsday for 2 days inter-session interval20 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
1 changes in N100-derived event-related-potential waveforms neurophysiological
2 changes glutamine-glutamate levels neurochemical
3 changes in resting-state functional connectivity neuroimaging and
4 reduction in AVH severity clinical
The secondary objectives of this study are
1 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
2 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
3 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None