Dream ContentNCT02731443
The Impact of Epilepsy Surgery on Dream Content
An observational study of Dream Content, run by London Health Sciences Centre at 1 site in Canada.
Trial summary
Prospective observational study on epilepsy patients undergoing partial brain resection surgery (i.e. anterior temporal lobectomy) to assess the change in dream content before and 3 months and 1 year after surgery using anonymized dream-recall questionnaires. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Dream Content
- What is being tested?
- Epilepsy surgery and Depth electrodes insertion
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2016to 30 Jun 2018
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Epilepsy patients undergoing elective surgical resection of brain tissue (study group: Epilepsy surgery=ESx) or depth electrode insertion in general anesthesia (control group=DE).
Who may be able to join
- All epilepsy patients (minimum age: 16 years) undergoing elective surgical resection of brain tissue (study group) or depth electrode insertion in general anesthesia (control group) that give written consent after thorough study information.
- Patients must be able to understand the study concept and willing/able to document their most recent dream in written.
Who cannot join
- Inability to document their most recent dream in written (language barrier, illiteracy, low intelligence, mental disabilities). Age <16 years.
- Relevant co-morbidities such as dementia, depression and other psychiatric disorders, Parkinson's disease.
- Previous cranial surgery in a relevant cortical area of the default dream network.
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Center, University Hospital
London, Ontario, N6A 5A5
About this study
Prospective observational study on epilepsy patients undergoing partial brain resection surgery (i.e. anterior temporal lobectomy) to assess the change in dream content before and 3 months and 1 year after surgery using anonymized dream-recall questionnaires. A control group of epilepsy patients undergoing diagnostic depth electrodes placement will complete the same questionnaires pre- and postoperatively to asses the factor 'general anesthesia' as a potential confounder.
Read the detailed description
STUDY RATIONALE Dream research, unlike sleep research, has not greatly developed anymore as there are few dream research laboratories only and not much systematic dream research is done outside the laboratory either(1) although validated methods of collecting and analyzing dream reports on the basis of the coding system developed by Calvin S. Hall and Robert Van de Castle are readily available.(2) According to Domhoff et al.,(3) the main features of the default dream network include the medial prefrontal cortex, the medial temporal lobe, the bilateral inferior parietal lobule/temporoparietal junction, and the posterior cingulate cortex, with the medial pre- frontal cortex and the posterior cingulate cortex serving as major hubs. The dorsal medial subsystem including the dorsomedial prefrontal cortex, the temporoparietal junction/anterior inferior parietal lobule, the lateral temporal cortex, and temporopolar cortex (the anterior pole of the temporal lobe) is activated by instructions to think about the present situation or a present mental state (''present self'').(3) The medial temporal subsystem including the ventral medial prefrontal cortex, posterior inferior parietal lobule, retrosplenial cortex, parahippocampal cortex, and hippocampal formation is activated by thinking about personal situations and decisions in the future (''future self'').(3) A lot of what is known about the neuronal function of dreaming comes from lesion studies that are well-summarized by Solms.(4) To the best knowledge, investigators are the first to prospectively investigate the change of dream content in patients electively undergoing surgical resection of brain tissue (i.e. the anterior temporal lobe for temporal lobe epilepsy).
The merits of the current study are the following:
- To better understand the dream network (academic significance)
- To better consult epilepsy patients with respect to the impact of surgery on dreaming (practical significance)
PURPOSES AND OBJECTIVES
Purpose:
- To assess the change in dream content in patients following epilepsy surgery compared to a control group of patients undergoing general anesthesia.
Hypothesis:
- Dream content is markedly changed in patients before and after epilepsy surgery.
Objective:
- To quantify dream content in patients before and after epilepsy surgery using the MOST RECENT DREAM questionnaire and compare these results to patients undergoing general anesthesia (control group).
STUDY DESIGN AND METHODOLOGY Setting/Design: Prospective observational study on epilepsy patients undergoing elective surgical resection of brain tissue (study group: Epilepsy surgery=ESx) or depth electrode insertion in general anesthesia (control group=DE).
Methodology: Patient baseline characteristics are Age (minimum age: 16 years); Date of birth (DOB); Sex; Handedness: RH/LH; Education (years); Occupation according to the International Standard Classification of Occupation(5); Seizure history (years); Seizure frequency ENGEL classification; Antiepileptic drugs; Other medication (antidepressants, dopaminergic agonists and antagonists, etc.); Pathology (Ammon's horn sclerosis y/n); Side (right/left); Any previous cranial surgery; Other relevant medical history (dementia, depression and other psychiatric disorders, Parkinson's, etc.) Questionnaire: MOST RECENT DREAM (STANDARD INSTRUMENT (2)
STUDY PROCEDURES AND SPECIFIC TESTINGS In this observational study, the MOST RECENT DREAM questionnaire, a standard validated instrument(2) represents the only study specific testing outside of standard care. The questionnaire is handed out to patients to record the most recent dreams five times pre- and post-operatively. The length of each dream summary lies in between 50 and 300 words. Study participation and the questionnaires will not affect standard patient care in any way and carries no additional risks.
STUDY GROUP:
Visit 1 (pre-op outpatient clinics or epilepsy monitoring unit) - Study information - Informed consent - Hand-out anonymized MOST RECENT DREAM (5x), return by mail before surgery.
Visit 2 (post-op outpatient clinics at ~1 month) - Hand-out anonymized MOST RECENT DREAM (5x) to be completed and returned by mail at 3 months postoperatively - Outcome according to the Engel classification Long-term FU at 12 month - Mail anonymized MOST RECENT DREAM (5x), return by mail.
CONTROL GROUP (Diagnostic depth electrodes):
Visit 1 (pre-op outpatient clinics/epilepsy monitoring unit) Study information - Informed consent - Hand-out anonymized MOST RECENT DREAM (5x), return before surgery.
Visit 2 (post-op epilepsy monitoring unit) Hand-out anonymized MOST RECENT DREAM (5x) to be completed and returned by mail at 1 month postoperatively.
DATA ANALYSIS Major indicators for main content categories in the Hall/Van de Castle system(2) are compared before and after the index procedure and results will be presented graphically similar to Bentes et al.(6). Data analysis is done using EXCEL spreadsheets available from http://www.dreamresearch.net/ and analysis performed as explained at http://www2.ucsc.edu/dreams/Info/statistics.html
- Conditions
- Dream Content
- Being tested
- Epilepsy surgery, Depth electrodes insertion
- Keywords
- dreaming, epilepsy, neurosurgery, temporal lobectomy
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epilepsy surgeryProcedure or surgery
Epilepsy surgery is a procedure that removes an area of the brain where seizures originate.
Depth electrodes insertionProcedure or surgery
Depth electrodes are inserted for monitoring/mapping the subsurface levels of the brain for the surgical treatment of epilepsy.
| Study group | Role | What they receive |
|---|---|---|
| ESx | Epilepsy patients undergoing elective surgical resection of brain tissue; study group: epilepsy surgery=ESx. Receives: Procedure: Epilepsy surgery | |
| DE | Epilepsy patients undergoing elective depth electrodes insertion in general anesthesia; control group: depth electrodes=DE. Receives: Procedure: Depth electrodes insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Change of Dream Features Occurrence (i.e. dream content; MOST RECENT DREAM questionnaire) - both groups (ESx & control group)
Percentage change of the following dream features occurrences according to the Hall/Van de Castle system are considered:
- Characters
- Social Interactions
- Aggression
- Friendliness
- Sexuality
- Activities (walking, talking, seeing, thinking, etc.)
- Success and Failure
- Misfortune and Good Fortune
- Emotions
- Settings
- Objects
- Descriptive Elements (modifiers, time, negatives)
The relative abundance of the dream content listed above will be expressed in percentage and postoperative changes compared to the preoperative baseline.
Relative differences between the indicators will be determined and statistically tested for significance. The one indicator that turns out to be statistically different from the rest will be considered the primary outcome measure. For an example, compare Bentes et al. 2011.
Measured: 3 months
Secondary outcomes (1)
Dream Content (MOST RECENT DREAM questionnaire) - ESx group
Major indicators for main content categories according to the Hall/Van de Castle system.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2016 (estimated)
- Study startMar 2016
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Dream ContentStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Steven, London Health Sciences Centre
- Investigators
- David A Steven, M.D., Principal investigator, London Health Science Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02731443
- Sponsor's protocol ID
- 107654
- Status last verified
- Feb 2020
- First submitted
- 2 Apr 2016
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Domhoff GW, Schneider A. New rationales and methods for quantitative dream research outside the laboratory. Sleep. 1998 Jun 15;21(4):398-404. doi: 10.1093/sleep/21.4.398.
PubMed 9646385Schneider A, Domhoff GW. The Quantitative Study of Dreams. Retrieved December 13 2015: http://www.dreamresearch.net/.
Domhoff GW, Fox KC. Dreaming and the default network: A review, synthesis, and counterintuitive research proposal. Conscious Cogn. 2015 May;33:342-53. doi: 10.1016/j.concog.2015.01.019. Epub 2015 Feb 24.
PubMed 25723600Solms M. Dreaming and REM sleep are controlled by different brain mechanisms. Behav Brain Sci. 2000 Dec;23(6):843-50; discussion 904-1121. doi: 10.1017/s0140525x00003988.
PubMed 11515144International Standard Classification of Occupations (ISCO). http://www.ilo.org/public/english/bureau/stat/isco/. Accessed 1st of August 2015.
Bentes C, Costa J, Peralta R, Pires J, Sousa P, Paiva T. Dream recall frequency and content in patients with temporal lobe epilepsy. Epilepsia. 2011 Nov;52(11):2022-7. doi: 10.1111/j.1528-1167.2011.03290.x. Epub 2011 Oct 17.
PubMed 22003885
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Epilepsy Surgery on Dream Content
- ClinicalTrials.gov ID
- NCT02731443
- Acronym / sponsor ID
- 107654
- Conditions
- Dream Content
- Keywords
- dreaming, epilepsy, neurosurgery, temporal lobectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- London Health Sciences CentreUniversity, hospital or other
- Study start
- Mar 2016 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 7 Apr 2016 (estimated)
- 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.
Prospective observational study on epilepsy patients undergoing partial brain resection surgery (i.e. anterior temporal lobectomy) to assess the change in dream content before and 3 months and 1 year after surgery using anonymized dream-recall questionnaires. A control group of epilepsy patients undergoing diagnostic depth electrodes placement will complete the same questionnaires pre- and postoperatively to asses the factor 'general anesthesia' as a potential confounder.
Detailed description
STUDY RATIONALE Dream research, unlike sleep research, has not greatly developed anymore as there are few dream research laboratories only and not much systematic dream research is done outside the laboratory either(1) although validated methods of collecting and analyzing dream reports on the basis of the coding system developed by Calvin S. Hall and Robert Van de Castle are readily available.(2) According to Domhoff et al.,(3) the main features of the default dream network include the medial prefrontal cortex, the medial temporal lobe, the bilateral inferior parietal lobule/temporoparietal junction, and the posterior cingulate cortex, with the medial pre- frontal cortex and the posterior cingulate cortex serving as major hubs. The dorsal medial subsystem including the dorsomedial prefrontal cortex, the temporoparietal junction/anterior inferior parietal lobule, the lateral temporal cortex, and temporopolar cortex (the anterior pole of the temporal lobe) is activated by instructions to think about the present situation or a present mental state (''present self'').(3) The medial temporal subsystem including the ventral medial prefrontal cortex, posterior inferior parietal lobule, retrosplenial cortex, parahippocampal cortex, and hippocampal formation is activated by thinking about personal situations and decisions in the future (''future self'').(3) A lot of what is known about the neuronal function of dreaming comes from lesion studies that are well-summarized by Solms.(4) To the best knowledge, investigators are the first to prospectively investigate the change of dream content in patients electively undergoing surgical resection of brain tissue (i.e. the anterior temporal lobe for temporal lobe epilepsy).
The merits of the current study are the following:
- To better understand the dream network (academic significance)
- To better consult epilepsy patients with respect to the impact of surgery on dreaming (practical significance)
PURPOSES AND OBJECTIVES
Purpose:
- To assess the change in dream content in patients following epilepsy surgery compared to a control group of patients undergoing general anesthesia.
Hypothesis:
- Dream content is markedly changed in patients before and after epilepsy surgery.
Objective:
- To quantify dream content in patients before and after epilepsy surgery using the MOST RECENT DREAM questionnaire and compare these results to patients undergoing general anesthesia (control group).
STUDY DESIGN AND METHODOLOGY Setting/Design: Prospective observational study on epilepsy patients undergoing elective surgical resection of brain tissue (study group: Epilepsy surgery=ESx) or depth electrode insertion in general anesthesia (control group=DE).
Methodology: Patient baseline characteristics are Age (minimum age: 16 years); Date of birth (DOB); Sex; Handedness: RH/LH; Education (years); Occupation according to the International Standard Classification of Occupation(5); Seizure history (years); Seizure frequency ENGEL classification; Antiepileptic drugs; Other medication (antidepressants, dopaminergic agonists and antagonists, etc.); Pathology (Ammon's horn sclerosis y/n); Side (right/left); Any previous cranial surgery; Other relevant medical history (dementia, depression and other psychiatric disorders, Parkinson's, etc.) Questionnaire: MOST RECENT DREAM (STANDARD INSTRUMENT (2)
STUDY PROCEDURES AND SPECIFIC TESTINGS In this observational study, the MOST RECENT DREAM questionnaire, a standard validated instrument(2) represents the only study specific testing outside of standard care. The questionnaire is handed out to patients to record the most recent dreams five times pre- and post-operatively. The length of each dream summary lies in between 50 and 300 words. Study participation and the questionnaires will not affect standard patient care in any way and carries no additional risks.
STUDY GROUP:
Visit 1 (pre-op outpatient clinics or epilepsy monitoring unit) - Study information - Informed consent - Hand-out anonymized MOST RECENT DREAM (5x), return by mail before surgery.
Visit 2 (post-op outpatient clinics at ~1 month) - Hand-out anonymized MOST RECENT DREAM (5x) to be completed and returned by mail at 3 months postoperatively - Outcome according to the Engel classification Long-term FU at 12 month - Mail anonymized MOST RECENT DREAM (5x), return by mail.
CONTROL GROUP (Diagnostic depth electrodes):
Visit 1 (pre-op outpatient clinics/epilepsy monitoring unit) Study information - Informed consent - Hand-out anonymized MOST RECENT DREAM (5x), return before surgery.
Visit 2 (post-op epilepsy monitoring unit) Hand-out anonymized MOST RECENT DREAM (5x) to be completed and returned by mail at 1 month postoperatively.
DATA ANALYSIS Major indicators for main content categories in the Hall/Van de Castle system(2) are compared before and after the index procedure and results will be presented graphically similar to Bentes et al.(6). Data analysis is done using EXCEL spreadsheets available from http://www.dreamresearch.net/ and analysis performed as explained at http://www2.ucsc.edu/dreams/Info/statistics.html
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESx | – | Procedure: Epilepsy surgeryEpilepsy patients undergoing elective surgical resection of brain tissue; study group: epilepsy surgery=ESx. |
| DE | – | Procedure: Depth electrodes insertionEpilepsy patients undergoing elective depth electrodes insertion in general anesthesia; control group: depth electrodes=DE. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Epilepsy patients undergoing elective surgical resection of brain tissue (study group: Epilepsy surgery=ESx) or depth electrode insertion in general anesthesia (control group=DE).
Key inclusion criteria (2 listed)
- All epilepsy patients (minimum age: 16 years) undergoing elective surgical resection of brain tissue (study group) or depth electrode insertion in general anesthesia (control group) that give written consent after thorough study information.
- Patients must be able to understand the study concept and willing/able to document their most recent dream in written.
Key exclusion criteria (3 listed)
- Inability to document their most recent dream in written (language barrier, illiteracy, low intelligence, mental disabilities). Age <16 years.
- Relevant co-morbidities such as dementia, depression and other psychiatric disorders, Parkinson's disease.
- Previous cranial surgery in a relevant cortical area of the default dream network.
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 |
|---|---|---|
| Epilepsy surgeryEpilepsy surgery is a procedure that removes an area of the brain where seizures originate. | Procedure or surgery | ESx |
| Depth electrodes insertionDepth electrodes are inserted for monitoring/mapping the subsurface levels of the brain for the surgical treatment of epilepsy. | Procedure or surgery | DE |
Primary outcome
Percentage Change of Dream Features Occurrence (i.e. dream content; MOST RECENT DREAM questionnaire) - both groups (ESx & control group)
Time frame: 3 months
Percentage change of the following dream features occurrences according to the Hall/Van de Castle system are considered: * Characters * Social Interactions * Aggression * Friendliness * Sexuality * Activities (walking, talking, seeing, thinking, etc.) * Success and Failure * Misfortune and Good Fortune * Emotions * Settings * Objects * Descriptive Elements (modifiers, time, negatives) The relative abundance of the dream content listed above will be expressed in percentage and postoperative changes compared to the preoperative baseline. Relative differences between the indicators will be determined and statistically tested for significance. The one indicator that turns out to be statistically different from the rest will be considered the primary outcome measure. For an example, compare Bentes et al. 2011.
1 secondary outcome
Dream Content (MOST RECENT DREAM questionnaire) - ESx group
Time frame: 12 months
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 20 Feb 2020.
- Results publication: PubMed 9646385Domhoff GW, Schneider A. New rationales and methods for quantitative dream research outside the laboratory. Sleep. 1998 Jun 15;21(4):398-404. doi: 10.1093/sleep/21.4.398.
- Results publicationSchneider A, Domhoff GW. The Quantitative Study of Dreams. Retrieved December 13 2015: http://www.dreamresearch.net/.
- Results publication: PubMed 25723600Domhoff GW, Fox KC. Dreaming and the default network: A review, synthesis, and counterintuitive research proposal. Conscious Cogn. 2015 May;33:342-53. doi: 10.1016/j.concog.2015.01.019. Epub 2015 Feb 24.
- Results publication: PubMed 11515144Solms M. Dreaming and REM sleep are controlled by different brain mechanisms. Behav Brain Sci. 2000 Dec;23(6):843-50; discussion 904-1121. doi: 10.1017/s0140525x00003988.
- Results publicationInternational Standard Classification of Occupations (ISCO). http://www.ilo.org/public/english/bureau/stat/isco/. Accessed 1st of August 2015.
- Results publication: PubMed 22003885Bentes C, Costa J, Peralta R, Pires J, Sousa P, Paiva T. Dream recall frequency and content in patients with temporal lobe epilepsy. Epilepsia. 2011 Nov;52(11):2022-7. doi: 10.1111/j.1528-1167.2011.03290.x. Epub 2011 Oct 17.
Related trials for Dream Content
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Links Between Epileptic Activity, Sleep Disruption and Mental Content During Sleep
Patients With Drug-resistant Focal Epilepsy, SEEG as Part of Presurgical Evaluation
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.
David A Steven, M.D. principal investigator
London Health Science Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dream Content, run by London Health Sciences Centre at 1 site in Canada.
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 2 inclusion and 3 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 20 Feb 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 Canada. 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 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?
Percentage Change of Dream Features Occurrence (i.e. dream content; MOST RECENT DREAM questionnaire) - both groups (ESx & control group) (time frame: 3 months). 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 NCT02731443, which also lists 6 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 20 Feb 2020.