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

NCT01418820 | Completed Phase 2

• 1 other identifier: EBS-PP-2011-02-16-001
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

hemianopia; visual field defect; stroke; non-invasive brain stimulation; alternating current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• detection accuracy (%) in the intact visual field over baseline

  baseline to 8 weeks after stimulation

• visual acuity (LogRAD)

  baseline to 8 weeks after stimulation

• EEG parameters

  baseline to 8 weeks after stimulation

• conventional perimetry

  baseline to 8 weeks after stimulation

• reaction time (ms)

  baseline to 8 weeks after stimulation

Study Arms (2)

Verum stimulation

EXPERIMENTAL

repetitive transorbital alternating current stimulation (rtACS)

Device: Verum stimulation

Placebo stimulation

SHAM COMPARATOR

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

Device: Placebo stimulation

Interventions

Verum stimulation 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.

Verum stimulation

Placebo stimulation 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.

Placebo stimulation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• lesion of the tractus opticus or of the visual cortex
• lesion age \> 6 months
• stable visual field defect with residual vision

You may not qualify if:

• 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%

Sponsors & Collaborators

• University of Magdeburg: lead
• EBS Technologies GmbH: collaborator

Study Sites (1)

Inst. f. Medical Psychology, Univ. of Magdeburg

Magdeburg, 39120, Germany

Location

Related Publications (1)

• 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.

  PMID: 34219679 DERIVED

MeSH Terms

Conditions

Scotoma; Hemianopsia; Stroke; Hemorrhage; Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Blindness; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Bernhard A Sabel, Ph.D.

  Univ. of Magdeburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: August 16, 2011
• First Posted: August 17, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

DE (1)