SchizophreniaNCT03892876
Trial of Stimulus-response Potentiation in Schizophrenia
A study testing Auditory High Frequency Tetanizing Stimulation in people with Schizophrenia, run by Cairo University at 1 site in Egypt.
Trial summary
This clinical trial aims at examining the effects of auditory high-frequency stimulation in schizophrenia patient, aiming to increase their AEPs, which are known to be attenuated from previous literature Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Auditory High Frequency Tetanizing Stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2019to 15 Apr 2021
- 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 20 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Able to give written informed consent
- Males (ages 20-50 years)
- Diagnosis of schizophrenia as confirmed by Structured Clinical Interview for DSM-V-TR (SCID)
- on stable doses of antipsychotic medications for at least 15 days
- scores 4 or more on at least one item of the Positive and Negative Syndrome Scale.
- able to give written informed consent
- males (ages 20-50).
Who cannot join
- History of / or current medical/neurological illnesses e.g. mental retardation (DSM-V) or epilepsy or significant head trauma
- Any type of hearing deficit will be excluded by audiometry assessment
- Substance abuse in the past 2 months
- medical conditions that make it difficult for the patient to visit the clinic in the designed schedule.
- For control group:
- History of / or current medical/neurological illnesses e.g. mental retardation (DSM-V) or epilepsy or significant head trauma
Show all 9Show fewer
- Any type of hearing deficit
- if they meet any axis-I diagnosis according to DSM-V confirmed by SCID.
- scores 2 or more on one item of the Positive and Negative Syndrome Scale
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Department of Psychiatry-Faculty of medicine-University of Cairo
Cairo, Cairo Governerate, 11562
About this study
Official title: Pilot Trial of Stimulus-response Potentiation in Schizophrenia
This clinical trial aims at examining the effects of auditory high-frequency stimulation in schizophrenia patient, aiming to increase their AEPs, which are known to be attenuated from previous literature
Read the detailed description
Schizophrenia is a chronic psychiatric disorder with a lifetime prevalence of 4.0 per 1,000. The introduction of antipsychotic medications in the 1950s resulted in marked clinical improvement in the symptom profile of schizophrenia, nevertheless the disease still contributes to a significant proportion of global disease burden in terms of both morbidity and mortality. In this regard, cognitive deficits and residual negative symptoms are considered major contributing factors to psychosocial disability and poor functional outcome associated with the disorder.
Higher-order cognitive functions; e.g. working memory and executive functions; show variable deficits and are considered a core clinical symptom of schizophrenia. On the other hand, the disorder is also characterized by abnormalities at the basic level of primary sensory processing, i.e. auditory, visual and somatosensory processing. Such abnormalities in the primary process of sensory perception could change the sensory experiences of schizophrenia patients and thus contribute to the psychopathology.
Event-related potentials (ERPs) are the neurophysiological correlates of sensory processing. ERP abnormalities have been widely described in schizophrenia literature: Pre-pulse inhibition of startle (PPI) in which a weaker pre-stimulus (pre-pulse) inhibits the reaction to a subsequent strong startling stimulus (pulse) is impaired in schizophrenia. P50 suppression, a measure of sensory gating, is also often absent or reduced in the disorder. N100; a measure of basic auditory sensory perception; shows significant amplitude reduction in patients compared to controls. Mismatch negativity (MMN), a measure of automatic deviance detection and shows characteristic attenuation in schizophrenia. P300, which is involved in higher-level stimulus evaluation and categorization, also shows abnormalities along the disease course.
In the study by Clapp et al., 2005, auditory high frequency stimulation (tetanizing stimulation) resulted in an increase in auditory-evoked potentials (AEPs) in healthy individuals; i.e. an increase in N1 amplitude that persisted even after stimulation. This augmentation of N1 amplitude was regarded as a result of plastic synaptic potentiation similar to long-term potentiation (LTP) described after electrical tetanic stimulation in cellular studies. Similar findings were later replicated by Lei et al., 2017, where they used pure tones, narrow band noises and white noise to induce stable potentiation and augmentation of N1 amplitude.
- Conditions
- Schizophrenia
- Being tested
- Auditory High Frequency Tetanizing Stimulation, Sham Comparator
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Auditory High Frequency Tetanizing StimulationDiagnostic test
50 ms tone pips presented at high frequency for 120 seconds
Sham ComparatorDiagnostic test
auditory tone pips with interstimulus interval (ISI) 1 sec
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia TS+ve | Experimental | Schizophrenia patients who receive auditory high frequency Tetanizing Stimulation Receives: Diagnostic Test: Auditory High Frequency Tetanizing Stimulation |
| Schizophrenia TS-ve | Sham comparator | Schizophrenia patients who receive sham comparator Receives: Diagnostic Test: Sham Comparator |
| Control TS+ve | Experimental | Healthy controls who receive auditory high frequency Tetanizing Stimulation Receives: Diagnostic Test: Auditory High Frequency Tetanizing Stimulation |
| Control TS-ve | Sham comparator | Healthy controls who receive sham comparator Receives: Diagnostic Test: Sham Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
N100 wave (AEP) amplitude in µv [microvolts]
N100 or N1 is a large, negative-going evoked potential measured by electroencephalography. It peaks in adults between 80 and 120 milliseconds after the onset of a stimulus, and distributed mostly over the fronto-central region of the scalp.
Measured: 1-2 hours
P300 wave amplitude in µv [microvolts] (auditory odd-ball task)
The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. It is considered to be an endogenous potential, as its occurrence links not to the physical attributes of a stimulus, but to a person's reaction to it. More specifically, the P300 is thought to reflect processes involved in stimulus evaluation or categorization.
Measured: 1-2 hours
Secondary outcomes (1)
performance of Wisconsin Card Sorting test (WCST).
Wisconsin Card Sorting Test (WCST) is a neuropsychological test of "set-shifting", i.e. the ability to display flexibility in the face of changing schedules of reinforcement.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2019
- Study start1 Sep 2019
- Primary completion15 Apr 2021
- Study completion15 Apr 2021
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.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pittsburgh
- Responsible party
- Principal investigator, Kyrillos Meshreky, Cairo University
- Investigators
- Ola O Shahin, MD, Study director, Department of Psychiatry-University of CairoVishwajit L Nimgaonkar, PhD, Study director, Department of Psychiatry-University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03892876
- Sponsor's protocol ID
- N-173-2019
- Status last verified
- Jun 2021
- First submitted
- 25 Mar 2019
- Last updated
- 1 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Stimulus-response Potentiation in Schizophrenia
- ClinicalTrials.gov ID
- NCT03892876
- Acronym / sponsor ID
- N-173-2019
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- University of Pittsburgh
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 15 Apr 2021 (actual)
- Study completion
- 15 Apr 2021 (actual)
- First posted
- 27 Mar 2019 (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 at examining the effects of auditory high-frequency stimulation in schizophrenia patient, aiming to increase their AEPs, which are known to be attenuated from previous literature
Detailed description
Schizophrenia is a chronic psychiatric disorder with a lifetime prevalence of 4.0 per 1,000. The introduction of antipsychotic medications in the 1950s resulted in marked clinical improvement in the symptom profile of schizophrenia, nevertheless the disease still contributes to a significant proportion of global disease burden in terms of both morbidity and mortality. In this regard, cognitive deficits and residual negative symptoms are considered major contributing factors to psychosocial disability and poor functional outcome associated with the disorder.
Higher-order cognitive functions; e.g. working memory and executive functions; show variable deficits and are considered a core clinical symptom of schizophrenia. On the other hand, the disorder is also characterized by abnormalities at the basic level of primary sensory processing, i.e. auditory, visual and somatosensory processing. Such abnormalities in the primary process of sensory perception could change the sensory experiences of schizophrenia patients and thus contribute to the psychopathology.
Event-related potentials (ERPs) are the neurophysiological correlates of sensory processing. ERP abnormalities have been widely described in schizophrenia literature: Pre-pulse inhibition of startle (PPI) in which a weaker pre-stimulus (pre-pulse) inhibits the reaction to a subsequent strong startling stimulus (pulse) is impaired in schizophrenia. P50 suppression, a measure of sensory gating, is also often absent or reduced in the disorder. N100; a measure of basic auditory sensory perception; shows significant amplitude reduction in patients compared to controls. Mismatch negativity (MMN), a measure of automatic deviance detection and shows characteristic attenuation in schizophrenia. P300, which is involved in higher-level stimulus evaluation and categorization, also shows abnormalities along the disease course.
In the study by Clapp et al., 2005, auditory high frequency stimulation (tetanizing stimulation) resulted in an increase in auditory-evoked potentials (AEPs) in healthy individuals; i.e. an increase in N1 amplitude that persisted even after stimulation. This augmentation of N1 amplitude was regarded as a result of plastic synaptic potentiation similar to long-term potentiation (LTP) described after electrical tetanic stimulation in cellular studies. Similar findings were later replicated by Lei et al., 2017, where they used pure tones, narrow band noises and white noise to induce stable potentiation and augmentation of N1 amplitude.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia TS+ve | Experimental | Diagnostic Test: Auditory High Frequency Tetanizing StimulationSchizophrenia patients who receive auditory high frequency Tetanizing Stimulation |
| Schizophrenia TS-ve | Sham comparator | Diagnostic Test: Sham ComparatorSchizophrenia patients who receive sham comparator |
| Control TS+ve | Experimental | Diagnostic Test: Auditory High Frequency Tetanizing StimulationHealthy controls who receive auditory high frequency Tetanizing Stimulation |
| Control TS-ve | Sham comparator | Diagnostic Test: Sham ComparatorHealthy controls who receive sham comparator |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Able to give written informed consent
- Males (ages 20-50 years)
- Diagnosis of schizophrenia as confirmed by Structured Clinical Interview for DSM-V-TR (SCID)
- on stable doses of antipsychotic medications for at least 15 days
- scores 4 or more on at least one item of the Positive and Negative Syndrome Scale.
Key exclusion criteria (9 listed)
- History of / or current medical/neurological illnesses e.g. mental retardation (DSM-V) or epilepsy or significant head trauma
- Any type of hearing deficit will be excluded by audiometry assessment
- Substance abuse in the past 2 months
- medical conditions that make it difficult for the patient to visit the clinic in the designed schedule.
- History of / or current medical/neurological illnesses e.g. mental retardation (DSM-V) or epilepsy or significant head trauma
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 |
|---|---|---|
| Auditory High Frequency Tetanizing Stimulation50 ms tone pips presented at high frequency for 120 seconds | Diagnostic test | Control TS+ve, Schizophrenia TS+ve |
| Sham Comparatorauditory tone pips with interstimulus interval (ISI) 1 sec | Diagnostic test | Control TS-ve, Schizophrenia TS-ve |
Primary outcome
N100 wave (AEP) amplitude in µv [microvolts]
Time frame: 1-2 hours
N100 or N1 is a large, negative-going evoked potential measured by electroencephalography. It peaks in adults between 80 and 120 milliseconds after the onset of a stimulus, and distributed mostly over the fronto-central region of the scalp.
P300 wave amplitude in µv [microvolts] (auditory odd-ball task)
Time frame: 1-2 hours
The P300 (P3) wave is an event related potential (ERP) component elicited in the process of decision making. It is considered to be an endogenous potential, as its occurrence links not to the physical attributes of a stimulus, but to a person's reaction to it. More specifically, the P300 is thought to reflect processes involved in stimulus evaluation or categorization.
1 secondary outcome
performance of Wisconsin Card Sorting test (WCST).
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2021.
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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.
Ola O Shahin, MD study director
Department of Psychiatry-University of Cairo
Vishwajit L Nimgaonkar, PhD study director
Department of Psychiatry-University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Auditory High Frequency Tetanizing Stimulation in people with Schizophrenia, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 1 Jul 2021. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
N100 wave (AEP) amplitude in µv [microvolts] (time frame: 1-2 hours). The study lists 2 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 1 Jul 2021.