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

University of Magdeburg

Status and phase: Completed; Phase 2

Conditions: Hemorrhage; Stroke; Complete Hemianopia; Scotoma; Quadrantanopia; Incomplete Hemianopia; Brain Trauma

Treatments: Device: Verum stimulation; Device: Placebo stimulation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01418820

EBS-PP-2011-02-16-001

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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32 participants in 2 patient groups

Verum stimulation

Experimental group

Description:

repetitive transorbital alternating current stimulation (rtACS)

Treatment:

Device: Verum stimulation

Placebo stimulation

Sham Comparator group

Description:

compared to verum stimulation the same electrode montage set-up is used during placebo stimulation, except that placebo patients receive a minimal stimulation

Treatment:

Device: Placebo stimulation