NCT02731443

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 2, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 7, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
Last Updated

February 20, 2020

Status Verified

February 1, 2020

Enrollment Period

2.3 years

First QC Date

April 2, 2016

Last Update Submit

February 18, 2020

Conditions

Keywords

dreamingepilepsyneurosurgerytemporal lobectomy

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Dream Content (MOST RECENT DREAM questionnaire) - ESx group

    12 months

Other Outcomes (2)

  • Seizure frequency (ESx only)

    3 and 12 months

  • Anti epileptic drugs (AED) usage (ESx only)

    3 and 12 months

Study Arms (2)

ESx

Epilepsy patients undergoing elective surgical resection of brain tissue; study group: epilepsy surgery=ESx.

Procedure: Epilepsy surgery

DE

Epilepsy patients undergoing elective depth electrodes insertion in general anesthesia; control group: depth electrodes=DE.

Procedure: Depth electrodes insertion

Interventions

Epilepsy surgery is a procedure that removes an area of the brain where seizures originate.

ESx

Depth electrodes are inserted for monitoring/mapping the subsurface levels of the brain for the surgical treatment of epilepsy.

DE

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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).

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (6)

  • 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.

  • Schneider A, Domhoff GW. The Quantitative Study of Dreams. Retrieved December 13 2015: http://www.dreamresearch.net/.

    RESULT
  • 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.

  • Solms 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.

  • International Standard Classification of Occupations (ISCO). http://www.ilo.org/public/english/bureau/stat/isco/. Accessed 1st of August 2015.

    RESULT
  • 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.

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David A Steven, M.D.

    London Health Science Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
David A. Steven, MD, MPH, FRCSC, FACS

Study Record Dates

First Submitted

April 2, 2016

First Posted

April 7, 2016

Study Start

March 1, 2016

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

February 20, 2020

Record last verified: 2020-02

Locations