Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Stroke Clinical Trial

Official title:

Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01418820
• Other study ID #: EBS-PP-2011-02-16-001
• Status: Completed
• Phase: Phase 2
• Start date: March 2011
• Est. completion date: December 2013

Study information

• Verified date: July 2019
• Source: University of Magdeburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.

It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• lesion of the tractus opticus or of the visual cortex

• lesion age > 6 months

• stable visual field defect with residual vision

Exclusion Criteria:

• electric or electronic implants, e.g. heart pacer

• any metal artefacts in the head

• Epilepsy

• Auto-immune diseases in acute stage

• mental diseases, e.g. schizophrenia etc.

• diabetic retinopathy

• addictive diseases

• blood pressure above 160/100 mmHg

• instable or high level of intraocular pressure above 27 mmHg

• retinitis pigmentosa

• pathological nystagmus

• presence of an un-operated tumor or tumor relapse (patients with non-progressive tumor are eligible if study participation is recommended by medical authorities)

• focal findings in EEG or photosensitivity (patients with single seizure more than 10 yrs ago may participate)

• recurrent transitional ischemic attacks after stroke

• arteriosclerosis of large blood vessels with stenosis >75%

• severe coronary heart disease (CHD)

• unstable angina pectoris

• diabetes with blood glucose level > 9 mmol/l

• myocard infarct/ cardiomyopathy

• ventricular fibrillation

• risk of vascular thrombosis

• pregnant or breast-feeding women

Related Conditions & MeSH terms

• Brain Injuries, Traumatic
• Brain Trauma
• Complete Hemianopia
• Hemianopsia
• Hemorrhage
• Incomplete Hemianopia
• Quadrantanopia
• Scotoma
• Stroke

Intervention

Device:
• Verum stimulation
10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion.
• Placebo stimulation
10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude.

Locations

Country	Name	City	State
Germany	Inst. f. Medical Psychology, Univ. of Magdeburg	Magdeburg

Sponsors (2)

Lead Sponsor	Collaborator
University of Magdeburg	EBS Technologies GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	detection accuracy (%) in visual field measures over baseline	visual stimuli detection accuracy in residual and absolutely defect visual field will be assessed using computer-based high resolution perimetry (HRP)	baseline to 8 weeks after stimulation
Secondary	detection accuracy (%) in the intact visual field over baseline	visual stimuli detection accuracy in the intact visual field will be assessed using computer-based high resolution perimetry (HRP)	baseline to 8 weeks after stimulation
Secondary	visual acuity (LogRAD)		baseline to 8 weeks after stimulation
Secondary	EEG parameters	entrainment of stimulation frequencies (EEG power spectra) and measures of functional connectivity	baseline to 8 weeks after stimulation
Secondary	conventional perimetry	visual fields obtained by static and kinetic perimetry (average threshold in db, average excentricity in degrees)	baseline to 8 weeks after stimulation
Secondary	reaction time (ms)	average reaction time in ms, measured by computer-based high resolution perimetry (HRP)	baseline to 8 weeks after stimulation