- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05389345
tDCS and Executive Function Training for Schizophrenia
Effects of Adding Transcranial Direct Current Stimulation to Executive Function Training for Schizophrenia-spectrum Disorders - a Randomized Control Trial
Study Overview
Status
Intervention / Treatment
Detailed Description
Schizophrenia-spectrum disorders are the most persistent, debilitating, and economically burdensome mental illnesses worldwide, and are associated with the greatest per-patient expense of all mental health conditions. Schizophrenia is associated with a 15-20 year decrease in life expectancy, 5-fold increase in likelihood of death by suicide, and a significant decrease in quality of life. Antipsychotic medications are the first line treatment for individuals with schizophrenia-spectrum disorders and are prescribed to nearly every service-user. However, in the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) trial (one of the largest antipsychotic trials in 1493 individuals with schizophrenia), medication effects on psychosocial functioning were small (d = 0.25). Thus, the primary treatment available to all individuals with schizophrenia does little to improve community functioning. This may partially be a result of the limited efficacy of antipsychotic medication to improve neurocognitive abilities, widely recognized as a core feature of schizophrenia, and one recommendation stemming from the CATIE trial was that "more intensive psychosocial rehabilitative services, including cognitive rehabilitation, may be needed to affect more substantial gains in functioning."
Cognitive remediation (CR) is a psychological intervention based on principles of learning and neuroplasticity to improve neurocognitive abilities with the ultimate goal of improving community functioning. The neuroplastic effects of CR are well established with evidence for increased gray matter volume in the hippocampus and amygdala, increased activation of the medial prefrontal cortex, and increased amplitude of the mismatch negativity event-related potential following CR. In two recent randomized controlled trials (RCTs), we also demonstrated that CR improves synchronization of neural networks in the alpha and theta frequency bands. Meta-analyses support moderate transfer of these neurophysiological improvements to neurocognitive abilities (d = 0.45) and community functioning (d = 0.37). In a recent systematic review, we reported that CR approaches vary widely, but approaches that incorporate training of executive functions are generally the most effective. Based on these findings we developed a novel CR intervention specifically targeting executive functions and conducted two double-blind RCTs, in which targeted executive function training (ET) produced greater improvements in neurophysiology, neurocognition, functional skills and real-world community functioning compared to other leading forms of CR. This intervention is approximately half the duration of other CR programs, yet produces larger effect size improvements in community functioning.
Further augmentation of CR is needed to increase effect size and impact on community functioning in schizophrenia. One such augmentation strategy is via interventions that are known to enhance neuroplasticity, which is the underlying mechanism of learning. A promising neuroplasticity enhancing methodology is via non-invasive brain stimulation.
Transcranial direct current stimulation (tDCs) is the most common form of non-invasive transcranial electric stimulation (tES). Unlike other forms of transcranial electric stimulation (for example electroconvulsive therapy of ECT), tDCS is designed to modify cortical excitability by making underlying neurons more or less likely to fire but is not designed to induce depolarization or action potential in the neurons. tDCS involves application of a weak, constant (i.e., "direct") electric current from one electrode (anode) placed on the scalp to another (cathode) in order to modify cortical excitability. The application strength can be measured by amplitude of the current applied (usually one or two Amperes) and duration of application (usually around 20-30 minutes). tDCS is thought to be relatively safe with main side effect of local skin irritation and local skin burn. The risk of inducing a seizure is extremely low (mainly pediatric case report evidence), and in fact tDCS has literature support suggesting potentially anti-seizure effects. tDCS has been investigated for several therapeutic applications including cognitive disorders with promising results. There are some preliminary studies that support the feasibility, safety and promising efficacy of tDCS in combination with CR in schizophrenia. These studies are generally small and focused on cognitive domains such as working memory. More studies are needed to evaluate the added value of tDCS on effect size and impact on executive and community functioning.
Although cognitive remediation approaches such as ET improve community functioning for people with schizophrenia-spectrum disorders, these approaches may be further refined to improve efficacy. One option is to combine ET with neurostimulation designed to prime the brain for enhanced learning. In order to further increase the efficiency and effectiveness of ET it is necessary to determine whether receiving tDCS prior to engaging in this cognitive training intervention may enhance one's ability to engage in cognitive activities, or may improve their cognitive abilities. This will provide important information regarding whether the outcomes of ET can be further enhanced, which will directly inform clinical methods and optimize the effectiveness of this treatment.
The primary goal of this study is to:
(1) Examine the efficacy of combined Executive Training and tDCS compared to Executive Training combined with sham tDCS on neurocognition and functioning.
The participants for this study will be recruited from Ontario Shores inpatient units, specifically Complex General Psychiatry (CGP) inpatient units, which historically averages a length of stay of 51 to 159 days depending on the specific unit and typically comprises 70 to 75 patients at any given time with diagnoses of schizophrenia/schizophrenia spectrum disorders. Inpatients who are not expected to be discharged for 4 weeks (period needed for study interventions) will be enrolled. However, if a participant is discharged before the end of the treatment, arrangements will be made for him/her to complete the intervention by coming on-site daily for tDCS and ET.
Participants will be randomized using an online random number table to receive actual tDCS prior to engaging in ET or sham tDCS prior to engaging in ET. All participants will receive ET. The randomization sequence will be pre-generated by the study coordinator who will then inform the treating clinician. Three assessments will be completed over the course of the study: one within 1 to 2 weeks of the start of the intervention, one within 1 to 2 weeks after the intervention is complete, and one 3-months after the intervention is complete. Each assessment will last about 2.5 hours and can be conducted over two days according to participant preference. These assessments will involve paper/pencil tests and questionnaires, computerized tests, and Electroencephalogram (EEG) recordings.
Primary and secondary outcomes will be examined using Linear Mixed Models on the Intent-to-Treat sample with missing data interpolated using maximum likelihood estimation. The primary endpoint is the 3-month follow-up assessment, and secondary endpoint of post-intervention will also be examined.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael W Best, PhD
- Phone Number: 647-601-4551
- Email: m.best@utoronto.ca
Study Contact Backup
- Name: Amer M Burhan, MBChB
- Phone Number: 6053 905-430-4055
- Email: burhana@ontarioshores.ca
Study Locations
-
-
Ontario
-
Whitby, Ontario, Canada, L1N 5S9
- Recruiting
- Ontario Shores Centre for Mental Health Sciences (Ontario Shores)
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- those who meet the criteria of schizophrenia, schizoaffective disorder or any other psychotic disorder based on the DSM-V criteria
- 18-65 years of age
- know how to use a computer
- are not abusing drugs or alcohol (criteria met for abuse in the last month)
- can read and speak English
Exclusion Criteria:
- anyone enrolled in a cognitive training program in the last 6 months
- anyone with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, medical history of head injury with loss of consciousness
- with a neurological disease or neurological damage, medical illnesses that can change neurocognitive function, medical history of head injury with loss of consciousness
- those with a seizure disorder
- those who are pregnant
- those with psychotic symptoms that in the opinion of the study psychiatrist, would impose risk of distress and/or decompensation of psychosis (e.g. delusion of influence through electricity)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Actual tDCs + ET
All interventions will involve 4 weeks of group intervention consisting of two 1-hour group sessions per week and additional practice between sessions.
Half of study participants will be randomized to receive 30 minutes of transcranial direct current stimulation (tDCS) prior to beginning each ET session.
ET session will begin immediately after tDCS.
|
Participants will receive bilateral prefrontal anodal stimulation with cathode placed on the back of the upper neck.
Transcranial direct current stimulation (tDCS) will be delivered by a research assistant under the supervision of a psychiatrist.
Other Names:
The Executive Training (ET) aspect of the study will be completed by all participants.
ET sessions consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises.
Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, on the unit or in the library at Ontario Shores between sessions.
ET will be delivered virtually and group sessions will be conducted using the online platform Zoom.
For any group sessions, a PHIPA and PIPEDA compliant license will be used.
This means that participants will not be able to record their screen using Zoom or a third-party program.
Dr. Best will also go through some rules during the first group Zoom session regarding the use of third-party equipment and the importance of confidentiality.
Other Names:
|
SHAM_COMPARATOR: Sham tDCs + ET
All interventions will involve 4 weeks of group intervention consisting of two 1-hour group sessions per week and additional practice between sessions.
Half of study participants will be randomized to receive 30 minutes of sham transcranial direct current stimulation (tDCS) prior to beginning each ET session.
ET session will begin immediately after tDCS.
During the sham tDCS, the procedures will be exactly the same as the real tDCS (e.g., application of electrodes), however, no stimulation will be provided when the device turned on.
|
The Executive Training (ET) aspect of the study will be completed by all participants.
ET sessions consist of 50% of the session practicing computerized cognitive training exercises, and 50% of the session developing cognitive strategies to use in the computerized exercises.
Participants are encouraged to complete 40 minutes of computerized training per day, and complete strategy worksheets, on the unit or in the library at Ontario Shores between sessions.
ET will be delivered virtually and group sessions will be conducted using the online platform Zoom.
For any group sessions, a PHIPA and PIPEDA compliant license will be used.
This means that participants will not be able to record their screen using Zoom or a third-party program.
Dr. Best will also go through some rules during the first group Zoom session regarding the use of third-party equipment and the importance of confidentiality.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Specific Levels of Functioning (SLOF)
Time Frame: Change from baseline to 3-month follow-up
|
The SLOF scale is a measure of community functioning
|
Change from baseline to 3-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The CANTAB is a battery consisting of highly sensitive, precise and objective measures of cognitive function.
It includes tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Reading subtest of the Wide Range Achievement Test (WRAT)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The WRAT is an academic skills assessment which measures reading skills and provides an estimate of premorbid intellectual ability.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Questionnaire About the Process of Recovery (QPR)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The QPR was developed from service users' accounts of recovery from psychosis in collaboration with local service users.
It asks people living with psychosis about aspects of recovery that are meaningful to them, and is strongly associated with general psychological wellbeing, quality of life and empowerment.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Brief Psychiatric Rating Scale (BPRS)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The BPRS measures psychopathology and symptom severity and is sensitive to changes in symptom levels
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The Q-LES-Q is a sensitive measure of the degree of enjoyment and satisfaction experienced by subjects in various areas of daily functioning.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Dysfunctional Attitudes Scale (DAS)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The DAS measures self-defeating attitudes theorized to underlie clinical depression and anxiety.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Brief Core Schema Scale (BCSS)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The BCSS assess four dimensions of self and other evaluation: negative-self, positive-self, negative-other, and positive-other
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Generalized Self-Efficacy Scale (GSES)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The GSES assess optimistic self-beliefs to cope with a variety of difficult demands in life
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Cognitive Failures Questionnaire (CFQ)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The CFQ was designed to measure perception, memory, and motor lapses in daily life
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Need for Cognition Scale (NCS)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The NCS measures the tendency for an individual to engage in and enjoy thinking
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baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Davos Assessment of Cognitive Biases (DACOBS)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The DACOBS measures cognitive biases and discriminates between schizophrenia-spectrum patients and normal control subjects
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Motivation and Pleasure Scale - Self-Report (MAP-SR)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
The MAP-SR assess the motivation and pleasure domains of negative symptoms.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Electroencephalogram (EEG)
Time Frame: baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
EEG will also be assessed using the Emotiv portable EEG system to assess neural synchronization to better understand how neural signatures change before and after the intervention.
All EEG will be performed at Ontario Shores.
Synchronization in the alpha and theta frequency bands during standard working memory and attention tests will be used to assess synchronization.
|
baseline within 1-2 weeks of start of intervention, 1-2 week follow-up after intervention complete, 3-month follow up
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Eack SM, Hogarty GE, Cho RY, Prasad KM, Greenwald DP, Hogarty SS, Keshavan MS. Neuroprotective effects of cognitive enhancement therapy against gray matter loss in early schizophrenia: results from a 2-year randomized controlled trial. Arch Gen Psychiatry. 2010 Jul;67(7):674-82. doi: 10.1001/archgenpsychiatry.2010.63. Epub 2010 May 3.
- Subramaniam K, Luks TL, Fisher M, Simpson GV, Nagarajan S, Vinogradov S. Computerized cognitive training restores neural activity within the reality monitoring network in schizophrenia. Neuron. 2012 Feb 23;73(4):842-53. doi: 10.1016/j.neuron.2011.12.024.
- Endicott J, Nee J, Harrison W, Blumenthal R. Quality of Life Enjoyment and Satisfaction Questionnaire: a new measure. Psychopharmacol Bull. 1993;29(2):321-6.
- Matsumoto H, Ugawa Y. Adverse events of tDCS and tACS: A review. Clin Neurophysiol Pract. 2016 Dec 21;2:19-25. doi: 10.1016/j.cnp.2016.12.003. eCollection 2017.
- Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
- Wu EQ, Birnbaum HG, Shi L, Ball DE, Kessler RC, Moulis M, Aggarwal J. The economic burden of schizophrenia in the United States in 2002. J Clin Psychiatry. 2005 Sep;66(9):1122-9. doi: 10.4088/jcp.v66n0906.
- Palmer BA, Pankratz VS, Bostwick JM. The lifetime risk of suicide in schizophrenia: a reexamination. Arch Gen Psychiatry. 2005 Mar;62(3):247-53. doi: 10.1001/archpsyc.62.3.247.
- Eack SM, Newhill CE. Psychiatric symptoms and quality of life in schizophrenia: a meta-analysis. Schizophr Bull. 2007 Sep;33(5):1225-37. doi: 10.1093/schbul/sbl071. Epub 2007 Jan 4.
- Swartz MS, Perkins DO, Stroup TS, Davis SM, Capuano G, Rosenheck RA, Reimherr F, McGee MF, Keefe RS, McEvoy JP, Hsiao JK, Lieberman JA; CATIE Investigators. Effects of antipsychotic medications on psychosocial functioning in patients with chronic schizophrenia: findings from the NIMH CATIE study. Am J Psychiatry. 2007 Mar;164(3):428-36. doi: 10.1176/ajp.2007.164.3.428.
- Best MW, Milanovic M, Iftene F, Bowie CR. A Randomized Controlled Trial of Executive Functioning Training Compared With Perceptual Training for Schizophrenia Spectrum Disorders: Effects on Neurophysiology, Neurocognition, and Functioning. Am J Psychiatry. 2019 Apr 1;176(4):297-306. doi: 10.1176/appi.ajp.2018.18070849. Epub 2019 Mar 8.
- Best MW, Gale D, Tran T, Haque MK, Bowie CR. Brief executive function training for individuals with severe mental illness: Effects on EEG synchronization and executive functioning. Schizophr Res. 2019 Jan;203:32-40. doi: 10.1016/j.schres.2017.08.052. Epub 2017 Sep 19.
- Wykes T, Spaulding WD. Thinking about the future cognitive remediation therapy--what works and could we do better? Schizophr Bull. 2011 Sep;37 Suppl 2(Suppl 2):S80-90. doi: 10.1093/schbul/sbr064.
- Best MW, Bowie CR. A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Expert Rev Neurother. 2017 Jul;17(7):713-723. doi: 10.1080/14737175.2017.1331128. Epub 2017 May 24.
- Zhao H, Qiao L, Fan D, Zhang S, Turel O, Li Y, Li J, Xue G, Chen A, He Q. Modulation of Brain Activity with Noninvasive Transcranial Direct Current Stimulation (tDCS): Clinical Applications and Safety Concerns. Front Psychol. 2017 May 10;8:685. doi: 10.3389/fpsyg.2017.00685. eCollection 2017.
- Jahshan C, Rassovsky Y, Green MF. Enhancing Neuroplasticity to Augment Cognitive Remediation in Schizophrenia. Front Psychiatry. 2017 Sep 27;8:191. doi: 10.3389/fpsyt.2017.00191. eCollection 2017.
- Ekici B. Transcranial direct current stimulation-induced seizure: analysis of a case. Clin EEG Neurosci. 2015 Apr;46(2):169. doi: 10.1177/1550059414540647. No abstract available.
- CANTAB® [Cognitive assessment software]. Cambridge Cognition (2019). All rights reserved. www.cantab.com
- Ruse SA, Harvey PD, Davis VG, Atkins AS, Fox KH, Keefe RS. Virtual Reality Functional Capacity Assessment In Schizophrenia: Preliminary Data Regarding Feasibility and Correlations with Cognitive and Functional Capacity Performance. Schizophr Res Cogn. 2014 Mar;1(1):e21-e26. doi: 10.1016/j.scog.2014.01.004.
- Wilkinson, G. S., & Robertson, G. J. (2017). WRAT-5: Wide Range Achievement Test Professional Manual. Psychological Assessment Resources. https://books.google.ca/books?id=amQXtAEACAAJ
- Neil, S. T., Kilbride, M., Pitt, L., Nothard, S., Welford, M., Sellwood, W., & Morrison, A. P. (2009). The questionnaire about the process of recovery (QPR): A measurement tool developed in collaboration with service users. Psychosis, 1(2), 145-155. https://doi.org/10.1080/17522430902913450
- Faustman, W. O., & Overall, J. E. (1999). Brief Psychiatric Rating Scale. In M. E. Maruish (Ed.), The use of psychological testing for treatment planning and outcomes assessment (p. 791-830). Lawrence Erlbaum Associates Publishers.
- Weissman AN, Beck AT. Development and validation of the dysfunctional Attitude Scale: A preliminary investigation. Paper presented at the Association for the Advancement of Behavior Therapy; Chicago. 1978.
- Fowler D, Freeman D, Smith B, Kuipers E, Bebbington P, Bashforth H, Coker S, Hodgekins J, Gracie A, Dunn G, Garety P. The Brief Core Schema Scales (BCSS): psychometric properties and associations with paranoia and grandiosity in non-clinical and psychosis samples. Psychol Med. 2006 Jun;36(6):749-59. doi: 10.1017/S0033291706007355. Epub 2006 Mar 27.
- Schwarzer, R., & Jerusalem, M. (1995). Generalized Self-Efficacy scale. In J. Weinman, S. Wright, & M. Johnston, Measures in health psychology: A user's portfolio. Causal and control beliefs (pp. 35-37). Windsor, UK: NFER-NELSON.
- Cacioppo, J. T., & Petty, R. E. (1982). The need for cognition. Journal of Personality and Social Psychology, 42, 116-131.
- van der Gaag M, Schutz C, Ten Napel A, Landa Y, Delespaul P, Bak M, Tschacher W, de Hert M. Development of the Davos assessment of cognitive biases scale (DACOBS). Schizophr Res. 2013 Mar;144(1-3):63-71. doi: 10.1016/j.schres.2012.12.010. Epub 2013 Jan 15.
- Llerena K, Park SG, McCarthy JM, Couture SM, Bennett ME, Blanchard JJ. The Motivation and Pleasure Scale-Self-Report (MAP-SR): reliability and validity of a self-report measure of negative symptoms. Compr Psychiatry. 2013 Jul;54(5):568-74. doi: 10.1016/j.comppsych.2012.12.001. Epub 2013 Jan 22.
- Guleyupoglu B, Febles N, Minhas P, Hahn C, Bikson M. Reduced discomfort during high-definition transcutaneous stimulation using 6% benzocaine. Front Neuroeng. 2014 Jul 11;7:28. doi: 10.3389/fneng.2014.00028. eCollection 2014.
- Kurzeck AK, Kirsch B, Weidinger E, Padberg F, Palm U. Transcranial Direct Current Stimulation (tDCS) for Depression during Pregnancy: Scientific Evidence and What Is Being Said in the Media-A Systematic Review. Brain Sci. 2018 Aug 14;8(8):155. doi: 10.3390/brainsci8080155.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41543
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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