Working MemoryNCT03268694
Investigation of Oscillations Underlying Human Cognitive and Affective Processing Using Intracranial EEG
A study testing Working Memory Task, Reward Learning Task and Facial Emotion Recognition Task in people with Working Memory and Emotions, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: To investigate the electrophysiological correlates of human cognition and affective processing. Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery cortical mapping with continuous electrocorticography (ECoG) with intracranial electrodes. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Working Memory, Emotions
- What is being tested?
- Working Memory Task, Reward Learning Task and Facial Emotion Recognition Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2017to 29 Jul 2018
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of medically intractable epilepsy
- Capable of giving informed consent
- Aged 18 - 80 years, either sex
Who cannot join
- Major systemic illness
- Severe cognitive impairment defined as mini-mental state examination of less than 20
- Severe psychiatric illness
- Excessive use of alcohol or other substances
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Purpose: To investigate the electrophysiological correlates of human cognition and affective processing. Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery cortical mapping with continuous electrocorticography (ECoG) with intracranial electrodes. Procedures (methods): Participants will perform computer-based cognitive and affective processing tasks during routine long-term monitoring. Intracranial EEG will be collected during the task
Read the detailed description
Oscillations in different frequency bands like theta, alpha, beta, gamma and high gamma are thought to underlie processing of cognitive and emotional information. For example, theta (3 - 7 Hz) and alpha (8 - 12 Hz) oscillations are known to underlie working memory as well as attentional processing. Theta oscillations are known to differentiate emotional and neutral stimuli while gamma oscillations (30 - 50 Hz) are known to underlie rapid integration of information. The fact that these oscillations are also disrupted in neuropsychiatric disorders underline the importance of these oscillations.
A lot of our understanding of these oscillations come from non invasive methods in humans like electroencephalography (EEG), magnetoencephalography (MEG) and invasive methods in animal models. However, EEG and MEG measure oscillations that are generated by collective firing of large cortical patches thereby losing spatial resolution. Also activity from deeper structures like amygdala and hippocampus cannot be picked up in these modalities. Animal models often suffer from the poor translation of behavior from animals to humans and vice versa. Intracranial EEG or Electrocorticography (ECoG) helps overcome the drawbacks described above.
Studies using ECoG have become widespread and have been helpful in elucidating the functional roles of different brain regions in cognition and emotion. The investigators aim to utilize these established procedures to study the role of oscillations recorded from different brain regions in cognition and emotion.
Patients with medically refractory epilepsy undergo long-term invasive monitoring for surgical resection planning. Electrodes are implanted subdurally over seizure focus to identify seizure onset zone and patients are often in the epilepsy monitoring unit at the Neuroscience hospital for approximately a week. During this period, intracranial EEG is constantly acquired for clinical investigation. The investigators plan to recruit these patients while they undergo long-term monitoring to leverage the rare access to direct brain recordings and study the role of oscillations in cognitive and affective processing. Patients who provide informed consent to participate in the study will perform computer based cognitive and emotional processing tasks.
- Conditions
- Working Memory, Emotions
- Being tested
- Working Memory Task, Reward Learning Task, Facial Emotion Recognition Task
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working Memory TaskBehavioural
Also called Sternberg Task, N-Back Task
Sternberg Task Items, which can be visually presented alphabets, shapes or numbers or sound tones presented through speakers, will be presented to the participant. The participant will need to maintain the presented items in their memory and indicate, when a single probe item is presented, whether the probe item was present in the immediately preceding list by pressing a key on the keyboard.
N-Back Task Items are presented continuously sequentially and participants are instructed to indicate whether items are repeated n items before by pressing a key on the keyboard. The task is divided into blocks of 0,1,2,3 -back trials based on the 'n'. For example in the 2 - back task, the participant has to indicate if the item presented 2 items before matches the current item. Similar to the previous task, the items can be presented visually or auditorily.
Reward Learning TaskBehavioural
Also called Learning reversal task
Two abstract visual stimuli are presented on the screen and participant is asked to choose one. Unknown to the participant, each stimulus is associated with distinct probabilities of virtual reward such that one stimulus is associated with net gain while the other is associated with net loss. The participant's goal is to maximize the reward. Once the participant identifies the stimulus associated with net gain, the reward probabilities are reversed. This process is repeated 5 times.
Facial Emotion Recognition TaskBehavioural
On a given trial, participants will be presented with images of two faces side-by-side. The faces will either match in terms of emotion category (e.g., 2 anger faces) or not (e.g., an anger face and a fear face). Faces presented together will always be of the same gender but different identities. Participants will be asked to determine whether the two faces presented depict the same emotion category.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive and Emotion Processing Tasks | Experimental | As a part of the clinical monitoring, intracranial EEG is continuously collected when the participant is at the Epilepsy Monitoring Unit at the UNC Neuroscience Hospital. We will use an FDA approved EEG amplifier/data acquisition system to collect the research data. Computer-based tasks will be presented through a laptop and task related timing information will be transmitted from the laptop to the data acquisition system. Computer-based tasks will include Working Memory task, Reward Learning Task and Facial Emotion Recognition Task Receives: Behavioral: Working Memory Task; Behavioral: Reward Learning Task; Behavioral: Facial Emotion Recognition Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intracranial EEG Spectra Power
Spectral analysis of electrophysiology data will be performed using multi-taper fft and wavelet transforms. The measures will be compared between different epochs within the tasks to determine what oscillations are modulated by the task. The correlation between the measures described above and the task performance will also be estimated.
Measured: Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour
Secondary outcomes (2)
Task Performance: Reaction Times
For all the tasks described above, the time from when the response is prompted and when the response is obtained is collected as reaction time. Reaction time is measured in milliseconds.
Measured: 1 Hour
Intracranial EEG Functional Connectivity Analysis
Functional connectivity between the different electrodes will be measured using phase locking value and Granger causality.
Measured: Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2017
- Study start7 Aug 2017
- Primary completion29 Jul 2018
- Study completion29 Jul 2018
Why it stopped: Competition with other ongoing projects with this population.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Working MemoryStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Responsible party
- Sponsor
- Investigators
- Flavio Frohlich, PhD, Principal investigator, University of North Carolina, Chapel HillHae Won Shin, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03268694
- Sponsor's protocol ID
- 17-1301
- Other IDs
- R21NS094988-01A1
- Status last verified
- Jan 2020
- First submitted
- 29 Aug 2017
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsieh LT, Ranganath C. Frontal midline theta oscillations during working memory maintenance and episodic encoding and retrieval. Neuroimage. 2014 Jan 15;85 Pt 2(0 2):721-9. doi: 10.1016/j.neuroimage.2013.08.003. Epub 2013 Aug 8.
PubMed 23933041Klimesch W. alpha-band oscillations, attention, and controlled access to stored information. Trends Cogn Sci. 2012 Dec;16(12):606-17. doi: 10.1016/j.tics.2012.10.007. Epub 2012 Nov 7.
PubMed 23141428Sauseng P, Klimesch W, Heise KF, Gruber WR, Holz E, Karim AA, Glennon M, Gerloff C, Birbaumer N, Hummel FC. Brain oscillatory substrates of visual short-term memory capacity. Curr Biol. 2009 Nov 17;19(21):1846-52. doi: 10.1016/j.cub.2009.08.062.
PubMed 19913428Symons AE, El-Deredy W, Schwartze M, Kotz SA. The Functional Role of Neural Oscillations in Non-Verbal Emotional Communication. Front Hum Neurosci. 2016 May 25;10:239. doi: 10.3389/fnhum.2016.00239. eCollection 2016.
PubMed 27252638Bonnefond M, Jensen O. Alpha oscillations serve to protect working memory maintenance against anticipated distracters. Curr Biol. 2012 Oct 23;22(20):1969-74. doi: 10.1016/j.cub.2012.08.029. Epub 2012 Oct 4.
PubMed 23041197Khader PH, Jost K, Ranganath C, Rosler F. Theta and alpha oscillations during working-memory maintenance predict successful long-term memory encoding. Neurosci Lett. 2010 Jan 14;468(3):339-43. doi: 10.1016/j.neulet.2009.11.028. Epub 2009 Nov 14.
PubMed 19922772Miller EK, Buschman TJ. Cortical circuits for the control of attention. Curr Opin Neurobiol. 2013 Apr;23(2):216-22. doi: 10.1016/j.conb.2012.11.011. Epub 2012 Dec 22.
PubMed 23265963Bastos AM, Vezoli J, Bosman CA, Schoffelen JM, Oostenveld R, Dowdall JR, De Weerd P, Kennedy H, Fries P. Visual areas exert feedforward and feedback influences through distinct frequency channels. Neuron. 2015 Jan 21;85(2):390-401. doi: 10.1016/j.neuron.2014.12.018. Epub 2014 Dec 31.
PubMed 25556836Jacobs J, Kahana MJ. Direct brain recordings fuel advances in cognitive electrophysiology. Trends Cogn Sci. 2010 Apr;14(4):162-71. doi: 10.1016/j.tics.2010.01.005. Epub 2010 Feb 25.
PubMed 20189441Mendez-Bertolo C, Moratti S, Toledano R, Lopez-Sosa F, Martinez-Alvarez R, Mah YH, Vuilleumier P, Gil-Nagel A, Strange BA. A fast pathway for fear in human amygdala. Nat Neurosci. 2016 Aug;19(8):1041-9. doi: 10.1038/nn.4324. Epub 2016 Jun 13.
PubMed 27294508Huijgen J, Dinkelacker V, Lachat F, Yahia-Cherif L, El Karoui I, Lemarechal JD, Adam C, Hugueville L, George N. Amygdala processing of social cues from faces: an intracrebral EEG study. Soc Cogn Affect Neurosci. 2015 Nov;10(11):1568-76. doi: 10.1093/scan/nsv048. Epub 2015 May 11.
PubMed 25964498Murray RJ, Brosch T, Sander D. The functional profile of the human amygdala in affective processing: insights from intracranial recordings. Cortex. 2014 Nov;60:10-33. doi: 10.1016/j.cortex.2014.06.010. Epub 2014 Jun 19.
PubMed 25043736
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Oscillations Underlying Human Cognitive and Affective Processing Using Intracranial EEG
- ClinicalTrials.gov ID
- NCT03268694
- Acronym / sponsor ID
- 17-1301
- Conditions
- Working Memory, Emotions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Competition with other ongoing projects with this population.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Neurological Disorders and Stroke (NINDS)
- Study start
- 7 Aug 2017 (actual)
- Primary completion
- 29 Jul 2018 (actual)
- Study completion
- 29 Jul 2018 (actual)
- First posted
- 31 Aug 2017 (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.
Purpose: To investigate the electrophysiological correlates of human cognition and affective processing. Participants: Drug-resistant epilepsy patients undergoing epilepsy surgery cortical mapping with continuous electrocorticography (ECoG) with intracranial electrodes. Procedures (methods): Participants will perform computer-based cognitive and affective processing tasks during routine long-term monitoring. Intracranial EEG will be collected during the task
Detailed description
Oscillations in different frequency bands like theta, alpha, beta, gamma and high gamma are thought to underlie processing of cognitive and emotional information. For example, theta (3 - 7 Hz) and alpha (8 - 12 Hz) oscillations are known to underlie working memory as well as attentional processing. Theta oscillations are known to differentiate emotional and neutral stimuli while gamma oscillations (30 - 50 Hz) are known to underlie rapid integration of information. The fact that these oscillations are also disrupted in neuropsychiatric disorders underline the importance of these oscillations.
A lot of our understanding of these oscillations come from non invasive methods in humans like electroencephalography (EEG), magnetoencephalography (MEG) and invasive methods in animal models. However, EEG and MEG measure oscillations that are generated by collective firing of large cortical patches thereby losing spatial resolution. Also activity from deeper structures like amygdala and hippocampus cannot be picked up in these modalities. Animal models often suffer from the poor translation of behavior from animals to humans and vice versa. Intracranial EEG or Electrocorticography (ECoG) helps overcome the drawbacks described above.
Studies using ECoG have become widespread and have been helpful in elucidating the functional roles of different brain regions in cognition and emotion. The investigators aim to utilize these established procedures to study the role of oscillations recorded from different brain regions in cognition and emotion.
Patients with medically refractory epilepsy undergo long-term invasive monitoring for surgical resection planning. Electrodes are implanted subdurally over seizure focus to identify seizure onset zone and patients are often in the epilepsy monitoring unit at the Neuroscience hospital for approximately a week. During this period, intracranial EEG is constantly acquired for clinical investigation. The investigators plan to recruit these patients while they undergo long-term monitoring to leverage the rare access to direct brain recordings and study the role of oscillations in cognitive and affective processing. Patients who provide informed consent to participate in the study will perform computer based cognitive and emotional processing tasks.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive and Emotion Processing Tasks | Experimental | Behavioral: Working Memory Task, Behavioral: Reward Learning Task, Behavioral: Facial Emotion Recognition TaskAs a part of the clinical monitoring, intracranial EEG is continuously collected when the participant is at the Epilepsy Monitoring Unit at the UNC Neuroscience Hospital. We will use an FDA approved EEG amplifier/data acquisition system to collect the research data. Computer-based tasks will be presented through a laptop and task related timing information will be transmitted from the laptop to the data acquisition system. Computer-based tasks will include Working Memory task, Reward Learning Task and Facial Emotion Recognition Task |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of medically intractable epilepsy
- Capable of giving informed consent
- Aged 18 - 80 years, either sex
Key exclusion criteria (4 listed)
- Major systemic illness
- Severe cognitive impairment defined as mini-mental state examination of less than 20
- Severe psychiatric illness
- Excessive use of alcohol or other substances
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 |
|---|---|---|
| Working Memory TaskAlso: Sternberg Task, N-Back TaskSternberg Task Items, which can be visually presented alphabets, shapes or numbers or sound tones presented through speakers, will be presented to the participant. The participant will need to maintain the presented items in their memory and indicate, when a single probe item is presented, whether the probe item was present in the immediately preceding list by pressing a key on the keyboard. N-Back Task Items are presented continuously sequentially and participants are instructed to indicate whether items are repeated n items before by pressing a key on the keyboard. The task is divided into blocks of 0,1,2,3 -back trials based on the 'n'. For example in the 2 - back task, the participant has to indicate if the item presented 2 items before matches the current item. Similar to the previous task, the items can be presented visually or auditorily. | Behavioural | Cognitive and Emotion Processing Tasks |
| Reward Learning TaskAlso: Learning reversal taskTwo abstract visual stimuli are presented on the screen and participant is asked to choose one. Unknown to the participant, each stimulus is associated with distinct probabilities of virtual reward such that one stimulus is associated with net gain while the other is associated with net loss. The participant's goal is to maximize the reward. Once the participant identifies the stimulus associated with net gain, the reward probabilities are reversed. This process is repeated 5 times. | Behavioural | Cognitive and Emotion Processing Tasks |
| Facial Emotion Recognition TaskOn a given trial, participants will be presented with images of two faces side-by-side. The faces will either match in terms of emotion category (e.g., 2 anger faces) or not (e.g., an anger face and a fear face). Faces presented together will always be of the same gender but different identities. Participants will be asked to determine whether the two faces presented depict the same emotion category. | Behavioural | Cognitive and Emotion Processing Tasks |
Primary outcome
Intracranial EEG Spectra Power
Time frame: Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour
Spectral analysis of electrophysiology data will be performed using multi-taper fft and wavelet transforms. The measures will be compared between different epochs within the tasks to determine what oscillations are modulated by the task. The correlation between the measures described above and the task performance will also be estimated.
2 secondary outcomes
Task Performance: Reaction Times
Time frame: 1 Hour
Intracranial EEG Functional Connectivity Analysis
Time frame: Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour
Results and safety
The study was stopped early (reason given: Competition with other ongoing projects with this population.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 23933041Hsieh LT, Ranganath C. Frontal midline theta oscillations during working memory maintenance and episodic encoding and retrieval. Neuroimage. 2014 Jan 15;85 Pt 2(0 2):721-9. doi: 10.1016/j.neuroimage.2013.08.003. Epub 2013 Aug 8.
- Background: PubMed 23141428Klimesch W. alpha-band oscillations, attention, and controlled access to stored information. Trends Cogn Sci. 2012 Dec;16(12):606-17. doi: 10.1016/j.tics.2012.10.007. Epub 2012 Nov 7.
- Background: PubMed 19913428Sauseng P, Klimesch W, Heise KF, Gruber WR, Holz E, Karim AA, Glennon M, Gerloff C, Birbaumer N, Hummel FC. Brain oscillatory substrates of visual short-term memory capacity. Curr Biol. 2009 Nov 17;19(21):1846-52. doi: 10.1016/j.cub.2009.08.062.
- Background: PubMed 27252638Symons AE, El-Deredy W, Schwartze M, Kotz SA. The Functional Role of Neural Oscillations in Non-Verbal Emotional Communication. Front Hum Neurosci. 2016 May 25;10:239. doi: 10.3389/fnhum.2016.00239. eCollection 2016.
- Background: PubMed 23041197Bonnefond M, Jensen O. Alpha oscillations serve to protect working memory maintenance against anticipated distracters. Curr Biol. 2012 Oct 23;22(20):1969-74. doi: 10.1016/j.cub.2012.08.029. Epub 2012 Oct 4.
- Background: PubMed 19922772Khader PH, Jost K, Ranganath C, Rosler F. Theta and alpha oscillations during working-memory maintenance predict successful long-term memory encoding. Neurosci Lett. 2010 Jan 14;468(3):339-43. doi: 10.1016/j.neulet.2009.11.028. Epub 2009 Nov 14.
- Background: PubMed 23265963Miller EK, Buschman TJ. Cortical circuits for the control of attention. Curr Opin Neurobiol. 2013 Apr;23(2):216-22. doi: 10.1016/j.conb.2012.11.011. Epub 2012 Dec 22.
- Background: PubMed 25556836Bastos AM, Vezoli J, Bosman CA, Schoffelen JM, Oostenveld R, Dowdall JR, De Weerd P, Kennedy H, Fries P. Visual areas exert feedforward and feedback influences through distinct frequency channels. Neuron. 2015 Jan 21;85(2):390-401. doi: 10.1016/j.neuron.2014.12.018. Epub 2014 Dec 31.
- Background: PubMed 20189441Jacobs J, Kahana MJ. Direct brain recordings fuel advances in cognitive electrophysiology. Trends Cogn Sci. 2010 Apr;14(4):162-71. doi: 10.1016/j.tics.2010.01.005. Epub 2010 Feb 25.
- Background: PubMed 27294508Mendez-Bertolo C, Moratti S, Toledano R, Lopez-Sosa F, Martinez-Alvarez R, Mah YH, Vuilleumier P, Gil-Nagel A, Strange BA. A fast pathway for fear in human amygdala. Nat Neurosci. 2016 Aug;19(8):1041-9. doi: 10.1038/nn.4324. Epub 2016 Jun 13.
- Background: PubMed 25964498Huijgen J, Dinkelacker V, Lachat F, Yahia-Cherif L, El Karoui I, Lemarechal JD, Adam C, Hugueville L, George N. Amygdala processing of social cues from faces: an intracrebral EEG study. Soc Cogn Affect Neurosci. 2015 Nov;10(11):1568-76. doi: 10.1093/scan/nsv048. Epub 2015 May 11.
- Background: PubMed 25043736Murray RJ, Brosch T, Sander D. The functional profile of the human amygdala in affective processing: insights from intracranial recordings. Cortex. 2014 Nov;60:10-33. doi: 10.1016/j.cortex.2014.06.010. Epub 2014 Jun 19.
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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.
Flavio Frohlich, PhD principal investigator
University of North Carolina, Chapel Hill
Hae Won Shin, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working Memory Task, Reward Learning Task and Facial Emotion Recognition Task in people with Working Memory and Emotions, run by University of North Carolina, Chapel Hill at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 13 Jan 2020. 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 United States. 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. 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 was stopped early (reason given: Competition with other ongoing projects with this population.). Results are not available in the source record.
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?
Intracranial EEG Spectra Power (time frame: Intracranial EEG will be collected simultaneously when the participants perform the task. 1 Hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03268694, which also lists 12 linked publications.
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 13 Jan 2020.