Trial Outcomes & Findings for Transcranial Magnetic Stimulation for Epilepsy (NCT NCT02757547)

NCT ID: NCT02757547

Last Updated: 2020-07-23

Results Overview

The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Placebo compared to Active
• Results posted on: 2020-07-23

Participant Flow

Subjects participating in the study will undergo both arms. Subjects will first complete the Placebo Arm and then will complete the Active Arm.

Participant milestones

Measure	TMS Placebo Arm Followed by TMS Active Arm A placebo TMS coil is used for the Placebo Arm Transcranial magnetic stimulation - Placebo Arm: Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation. TMS Active Arm: An active TMS coil is used. Transcranial magnetic stimulation - Active Arm: Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total.
Overall Study STARTED	2
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transcranial Magnetic Stimulation for Epilepsy

Baseline characteristics by cohort

Measure	TMS - Placebo Arm Followed by Active Arm n=2 Participants A placebo TMS coil is used for the Placebo Arm: Transcranial magnetic stimulation - Placebo Arm: Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation. An active TMS coil is used for the Active Arm: Transcranial magnetic stimulation - Active Arm: Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	1 Participants n=93 Participants
Sex: Female, Male Male	1 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants
Region of Enrollment United States	2 participants n=93 Participants

PRIMARY outcome

Timeframe: Placebo compared to Active

Population: The study was initiated by Electrical Geodesics Inc. At the time of the acquisition it was determined that the study was not in compliance with the regulations and/or GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was monitored or collected therefore, no statistical analysis could be performed.

The primary outcome was determined to be measured by the reduction in seizure frequency compared to baseline.

Outcome measures

Outcome data not reported

Adverse Events

Transcranial Magnetic Stimulation - Placebo Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Transcranial Magnetic Stimulation - Active Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pat Olsen

Philips

Phone: (303) 475-3417

Email: pat.olsen@philips.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: LTE60