NCT01703143

Brief Summary

To investigate whether MR-guided laser induced thermal therapy in patients diagnosed with focal lesional epilepsy using the Visualase Thermal Therapy System is both a feasible and safe minimally invasive technique for control of seizures in such patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2011

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

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

May 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 10, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 26, 2015

Status Verified

January 1, 2015

Enrollment Period

3.7 years

First QC Date

October 5, 2012

Last Update Submit

January 23, 2015

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (1)

  • The number of seizures recorded in seizure diary

    Baseline to 1 year

Study Arms (1)

Laser Ablation

EXPERIMENTAL

Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Procedure: Laser ablation

Interventions

Laser ablationPROCEDURE

Laser ablation of focal lesions in patients with medically refractory partial epilepsy.

Laser Ablation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or older at entry to protocol.
  • History of MRI lesional-related epilepsy for at least one year.
  • Failure to respond to more than 2 anti-epileptic drugs at adequate dose and duration.
  • Candidate for resective epilepsy surgery.
  • Considered healthy enough to undergo surgery with general anesthesia.
  • The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
  • Must have 3 months of seizure frequency recorded prior to procedure.

You may not qualify if:

  • Presence of any non-MRI compatible implanted electronic device.
  • Presence of a metallic prosthetic or implant including artificial hips, knees, joints, or rods and screws.
  • Active Major depression
  • History of Suicide attempts
  • History of Non-Epileptic Behavioral Spells

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Epilepsy

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Study Officials

  • W Marsh, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

October 5, 2012

First Posted

October 10, 2012

Study Start

May 1, 2011

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

January 26, 2015

Record last verified: 2015-01

Locations

US(2)