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

NCT ID: NCT01418820

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Verum stimulation

repetitive transorbital alternating current stimulation (rtACS)

Group Type: EXPERIMENTAL

Verum stimulation

Intervention Type: DEVICE

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

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

Group Type: SHAM_COMPARATOR

Placebo stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

EBS Technologies GmbH

INDUSTRY

Sponsor Role: collaborator

University of Magdeburg

OTHER

Sponsor Role: lead

Responsible Party

Bernhard A. Sabel

Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bernhard A Sabel, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Univ. of Magdeburg

Locations

Inst. f. Medical Psychology, Univ. of Magdeburg

Magdeburg, , Germany

Countries

Germany

References

Raty S, Borrmann C, Granata G, Cardenas-Morales L, Schoenfeld A, Sailer M, Silvennoinen K, Holopainen J, De Rossi F, Antal A, Rossini PM, Tatlisumak T, Sabel BA. Non-invasive electrical brain stimulation for vision restoration after stroke: An exploratory randomized trial (REVIS). Restor Neurol Neurosci. 2021;39(3):221-235. doi: 10.3233/RNN-211198.

Reference Type: DERIVED

PMID: 34219679 (View on PubMed)

Other Identifiers

EBS-PP-2011-02-16-001

Identifier Type: -

Identifier Source: org_study_id