NCT00486239

Brief Summary

The purpose of the study is to assess the effects of temporal lobe epilepsy (TLE) on memory and emotional functioning. The study will evaluate the known lateralized neurological dysfunction(Right TLE versus Left TLE) on emotional verbal and visual memory function. Study data will assess the ability of participants with known lateralized neurological dysfunction (Right TLE versus Left TLE) to differentially perceive emotional stimuli. Another component of the study will evaluate possible changes in memory function for emotionally charged material following right or left temporal lobectomy for the treatment of medically intractable epilepsy. It is expected participants with known lateralized dysfunction will exhibit differential ability to discriminate emotional charged visual and verbal material.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2006

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 14, 2007

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

3.4 years

First QC Date

June 13, 2007

Last Update Submit

May 17, 2022

Conditions

Keywords

Epilepsymemoryemotion

Outcome Measures

Primary Outcomes (1)

  • Evaluate the effects of known lateralized neurological dysfunction (Right TLE versus Left TLE) on emotional memory function.

    1 year

Study Arms (3)

1

EXPERIMENTAL

Behavioral TLE 1A

Behavioral: TLE Arm 1Behavioral: Emotion Memory Test

2

EXPERIMENTAL

TLE Arm II

Behavioral: Emotion Memory Testing

B

EXPERIMENTAL

Control Arm B

Behavioral: Emotion Memory Testing

Interventions

TLE Arm 1BEHAVIORAL

Behavioral/cognitive testing

1

Behavioral/cognitive Measure

1

Behavioral/cognitive testing

2

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Referred to neurological institute at University Hospitals Case Medical Center for care of seizures/epilepsy
  • Referred to neuropsychology laboratory for evaluation
  • Participants must complete the routine check-in of all patients and sign consent and HIPAA forms.
  • Be, in the investigator's opinion, compliant, able to follow the investigator's instructions and visit the clinic on schedule, cooperative and reliable.
  • Be aged 18-64 years old.
  • Be able to provide documented informed consent.
  • Have a confirmed diagnosis of right or left temporal lobe epilepsy (TLE), which is made independent of their pre-surgical neuropsychological evaluation. Neurological disease must be confirmed by one (or more) of the following: (a) MRI study of the head, (b) CT study of the head, (c) EEG study, (d) Video-EEG study, (e) PET study of the head, (f) Neurological and Psychiatric exam by a physician.

You may not qualify if:

  • Referred from an attorney or their evaluation is part of a personal injury claim.
  • Be intoxicated from alcohol or other illicit substance.
  • Received Electroconvulsive (ECT) treatment within the last 21 days.
  • Have an MMSE score of 25 or less
  • Have undergone Deep Brain Stimulator (DBS) surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals Case Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Mike R Schoenberg, PhD

    University Hospitals Cleveland Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2007

First Posted

June 14, 2007

Study Start

October 1, 2006

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

May 18, 2022

Record last verified: 2022-05

Locations