Trial Outcomes & Findings for Transcranial Electrical Neuromodulation for Suppressing Epileptiform Discharges (NCT NCT02516228)

NCT ID: NCT02516228

Last Updated: 2020-07-22

Results Overview

The main efficacy endpoint will be the change from baseline in number of spikes per hour (spike rate), as assessed with routine dEEG sessions, at each visit and after each treatment sessions.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: Baseline and following the 5 day treatment session
• Results posted on: 2020-07-22

Participant Flow

Recruitment and treatment procedures were conducted in the Neurology clinic at Harborview Hospital. Six subjects were screened and enrolled from 12-02-15 to 04-28-17.

Participant milestones

Measure	GTEN 100 All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only. GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day. During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days.
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	GTEN 100 All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only. GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day. During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days.
Overall Study Lost to Follow-up	1
Overall Study Withdrawal by Subject	1
Overall Study Physician Decision	1

Baseline Characteristics

This study was running at the time of acquisition by Philips. The study execution was out of compliance from the regulations and GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was formally collected therefore, no statistical analysis was performed. Philips terminated the study.

Baseline characteristics by cohort

Measure	GTEN 100 n=6 Participants All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only. GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day. During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days.
Age, Continuous	39.3 years n=6 Participants
Sex: Female, Male Female	3 Participants n=6 Participants
Sex: Female, Male Male	3 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=6 Participants
Race (NIH/OMB) Asian	1 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	1 Participants n=6 Participants
Race (NIH/OMB) White	4 Participants n=6 Participants
Race (NIH/OMB) More than one race	0 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=6 Participants
Region of Enrollment United States	6 participants n=6 Participants

PRIMARY outcome

Timeframe: Baseline and following the 5 day treatment session

Population: This study was running at the time of acquisition by Philips. The study execution was out of compliance from GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was collected therefore, no statistical analysis was performed. Philips terminated the study.

The main efficacy endpoint will be the change from baseline in number of spikes per hour (spike rate), as assessed with routine dEEG sessions, at each visit and after each treatment sessions.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline measurement and the Nine Month visit

Population: This study was running at the time of acquisition by Philips. The study execution was out of compliance from the regulations and GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was collected therefore, no statistical analysis was performed. Philips terminated the study.

Weekly change in the number of seizures, assessed by the seizure diary in comparison to the mean weekly seizure frequency for the baseline evaluation period;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Nine months

Population: This study was running at the time of acquisition by Philips. The study execution was out of compliance from the regulations and GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was monitored or collected therefore, no statistical analysis was performed. Philips terminated the study.

Change of cognitive function testing score beyond the practice effect (estimated from norms) ;

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Nine months

Population: This study was running at the time of acquisition by Philips. The study execution was out of compliance from the regulations and GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was monitored or collected therefore, no statistical analysis was performed. Philips terminated the study.

Change from baseline in quality of life rating

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Measured at baseline. treatment and at the 9 month followup visit

Population: This study was running at the time of acquisition by Philips. The study execution was out of compliance from the regulations and GCP. There was no protocol, no statistical analysis plan, no case report forms and no data was monitored or collected therefore, no statistical analysis was performed. Philips terminated the study.

• With assessments of spike rates after treatment session and at visits at weeks 2, 4, 8, 16, and 24, the duration of any suppression in spike rate can be explored. All spike rates (baseline, treatment, and follow-up) will also be classified in relation to waking or sleep stage (N1, N2, N3).

Outcome measures

Outcome data not reported

Adverse Events

GTEN 100

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

GTEN 100 n=6 participants at risk All patients will receive treatment according to the protocol with the GTEN 100 device, pulsed only. GTEN 100: Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day. During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days.

Nervous system disorders Seizure

50.0% 3/6 • 9 months

Additional Information

Sr. Clinical Operations Manager

Philips

Phone: 3034753417

Email: pat.olsen@philips.com

Results disclosure agreements

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