Trial Outcomes & Findings for Trial of Alternating Current Stimulation in Optic Neuropathy (NCT NCT01270126)

Results Overview

Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

22 participants

Primary outcome timeframe

Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics

Results posted on

2020-11-09

Participant Flow

* Assessed for eligibility (n=325)from local institutional database and upon response on announcements in local newspapers from Nov 2006 - Dec 2008. * Excluded (n=303): not meeting inclusion criteria (n=248), declined to participate (n=40), other reasons (n=15)

Participant milestones

Participant milestones
Measure	rtACS (Verum Condition) Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.	Sham Stimulation (Placebo Condition) A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
Overall Study STARTED	12	10
Overall Study COMPLETED	12	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trial of Alternating Current Stimulation in Optic Neuropathy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	rtACS (Verum Condition) n=12 Participants Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.	Sham Stimulation (Placebo Condition) n=10 Participants A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)	Total n=22 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical >=65 years	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Age, Continuous	52.3 years STANDARD_DEVIATION 14.3 • n=5 Participants	51.9 years STANDARD_DEVIATION 17.3 • n=7 Participants	52.1 years STANDARD_DEVIATION 15.4 • n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Region of Enrollment Germany	12 participants n=5 Participants	10 participants n=7 Participants	22 participants n=5 Participants

PRIMARY outcome

Timeframe: Outcome measures were assessed at initial diagnostics (baseline) and after 10 days stimulation at post diagnostics

Central visual fields were assessed with computer-based high-resolution perimetry (HRP). Based on such plots, areas of the visual field were characterized as intact, partially damaged or absolutely impaired (blind). Detection accuracy (DA) change in percent above baseline within defective visual field sectors was defined as the primary outcome criterion.

Outcome measures

Outcome measures
Measure	rtACS (Verum Condition) n=12 Participants Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.	Sham Stimulation (Placebo Condition) n=10 Participants A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
Detection Accuracy (DA) Change in Percent Over Baseline Within Defective Visual Field Sectors	24.75 percent change Standard Deviation 22.40	39.16 percent change Standard Deviation 25.26

SECONDARY outcome

Timeframe: Nov 2006 - Dec 2010

Secondary outcome parameters included DA in static and kinetic perimetry, reaction time (RT) in HRP, visual acuity (VA), contrast vision, and EEG power spectra.

Outcome measures

Outcome data not reported

Adverse Events

rtACS (Verum Condition)

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Sham Stimulation (Placebo Condition)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	rtACS (Verum Condition) n=12 participants at risk Repetitive transorbital alternating current stimulation (rtACS) Repetitive transorbital alternating current stimulation : Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.	Sham Stimulation (Placebo Condition) n=10 participants at risk A clicking sound was presented and the same electrode montage set-up was used during rtACS- and placebo-stimulation, except that placebo patients received no current (stimulator turned off)
Skin and subcutaneous tissue disorders cutaneous sensation	41.7% 5/12 • Number of events 5 • 1 year Adverse events were cutaneous sensations (tingling) under the stimulation electrodes and temporary sleeping difficulties	0.00% 0/10 • 1 year Adverse events were cutaneous sensations (tingling) under the stimulation electrodes and temporary sleeping difficulties
Nervous system disorders sleeping difficulties	16.7% 2/12 • Number of events 2 • 1 year Adverse events were cutaneous sensations (tingling) under the stimulation electrodes and temporary sleeping difficulties	20.0% 2/10 • Number of events 2 • 1 year Adverse events were cutaneous sensations (tingling) under the stimulation electrodes and temporary sleeping difficulties

Additional Information

Prof. Bernhard A. Sabel

Otto-von-Guericke University of Magdeburg, Medical Faculty, Institute of Medical Psychology, Magdeburg, Germany

Phone: 0049 3916721800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place