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Treatment of Difficult to Control Focal Epilepsy With Repetitive Transcranial Magnetic Stimulation (rTMS)

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ClinicalTrials.gov Identifier: NCT01745952
Recruitment Status : Completed
First Posted : December 10, 2012
Results First Posted : April 26, 2016
Last Update Posted : April 26, 2016
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Epilepsies, Partial
Interventions: Device: figure-of-eight active rTMS coil
Device: round active rTMS coil
Device: sham rTMS coil (figure-of-eight)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Figure-of-eight Active Coil; Then Round Active Coil; Then Sham
  • rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
  • rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
  • rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
Round Active Coil; Then Sham; Then Figure-of-eight Active Coil
  • rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
  • rTMS using the sham coil, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
  • rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
Sham Coil; Then Figure-of-eight Active Coil; Then Round Active
  • rTMS using the sham coil over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
  • rTMS using the figure-of-eight active coil, at 90% of the resting motor threshold, over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period
  • rTMS using the round active coil, at 90% of the resting motor threshold over the epileptogenic region, in trains of 500 pulses with a total of 1500 pulses per day, during weekdays on two consecutive weeks.
  • 12 week follow-up period

Participant Flow:   Overall Study
    Figure-of-eight Active Coil; Then Round Active Coil; Then Sham   Round Active Coil; Then Sham; Then Figure-of-eight Active Coil   Sham Coil; Then Figure-of-eight Active Coil; Then Round Active
STARTED   4   4   3 
COMPLETED   3   3 [1]   3 
NOT COMPLETED   1   1   0 
[1] data of one patient not used due to no seizure diary entries on multiple occasions



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
All Participants description of the patients at the onset of the study

Baseline Measures
   All Participants 
Overall Participants Analyzed 
[Units: Participants]
 11 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   11 
>=65 years   0 
Age 
[Units: Years]
Mean (Full Range)
 35 
 (24 to 61) 
Gender 
[Units: Participants]
 
Female   7 
Male   4 
baseline seizure frequency per week 
[Units: Seizures/week]
Mean (Full Range)
 24.9 
 (0.5 to 124.6) 


  Outcome Measures

1.  Primary:   50% Responder Rate After Active rTMS Treatment Compared With Placebo Treatment   [ Time Frame: week 12 after each intervention ]

2.  Secondary:   Percentage of Seizure Reduction After Active rTMS Treatment Compared With Placebo Treatment   [ Time Frame: week 12 after each treatment ]

3.  Other Pre-specified:   Alteration of Brain Activation as Measured by 18-2-fluoro-2-deoxy-D-glucose Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) on Individual Patient Level   [ Time Frame: within one week after the last treatment day of each session ]

4.  Other Pre-specified:   Difference in Seizure Reduction Using Different Coil Types   [ Time Frame: 9 months ]

5.  Other Pre-specified:   Questionnaires: Quality of Life in Epilepsy (QOLIE-31), Global Impression of Change-scales, Visual Analogue Scale, Columbia Suicide Severity Rating Scale   [ Time Frame: before the first treatment of each session and at the last evaluation visit ]

6.  Other Pre-specified:   Drop Out-rate   [ Time Frame: during the 9 months of the study ]

7.  Other Pre-specified:   Adverse Event Rate   [ Time Frame: during the 9 months of the study ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Prof W Van Paesschen & Dr L Seynaeve
Organization: UZ Leuven
phone: +3216349062
e-mail: laura.seynaeve@uzleuven.be


Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01745952     History of Changes
Other Study ID Numbers: s52486
First Submitted: December 4, 2012
First Posted: December 10, 2012
Results First Submitted: December 15, 2015
Results First Posted: April 26, 2016
Last Update Posted: April 26, 2016