Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

NCT04010994 — Phase 1 / Phase 2, Unknown, 50 participants, University of Magdeburg

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study

Registry	NCT04010994, acronym HomeStim
Status	Unknown
Phase	Phase 1 / Phase 2
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	50 (Actual)
Sponsor	University of Magdeburg (Other)
Conditions	Glaucoma, Electrical Stimulation, Home Treatment
Interventions	Transorbital electrical stimulation (Procedure)
Dates	start 2019-08-05, primary completion 2020-07-30 (estimated), completion 2020-12-31 (estimated), first posted 2019-07-08, last updated 2019-10-03
Locations	1 site in Germany

-Summary

The aim of the present study is to investigate the possibilities of visual field enhancement with electrical stimulation (ES) as a home stimulation method, in a total of 50 patients with optical neuropathy, who have already been treated with ES in the past.

Furthermore, factors responsible for response variability and treatment effectiveness are also explored: (i) the role of mental stress (or stress resilience), (ii) the status of biomarkers, such as the systemic stress hormone levels and blood supply to the eye and brain (specifically vascular dysregulation) and (iii) the influence of personality, anxiety, depression and lifestyle. The study serves to further validate this ES procedure for the treatment of visual impairment. Specifically, better efficacy, better compliance, lowest response variability are expected after long-term home use.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
rtACS	Other	Procedure: Transorbital electrical stimulation	repetitive transorbital ACS

Transorbital electrical stimulation (Procedure): Transorbital ACS using 8-12 Hz with 0,5-1,5 mA Intensity, during the first two weeks 1/day, after 2/week for 10 weeks, as a home treatment

+Outcome measures

Primary outcomes

Visual field size [3 months]: Static perimetry and high resolution perimetry will be used to measure the visual field sizes

Secondary outcomes

EEG connectivities in the visual system [3 months]: EEG recordings will be done using 128 channels, power spectra will be determined
Level of vascular regulation/dysregulation in the eye [3 months]: Dynamic vessel analysis will be used the measure blood flow in the eye

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patients with glaucoma, disease duration at least 6 months
* stable visual field defect across baseline measurement (subjects with spontaneous fluctuations and recovery of vision excluded)
* presence of residual vision and detectable gradual transition between the intact and the absolutely blind part of the visual field according to evaluation of the clinician
* best corrected visual acuity at least 0.4 (20/50 Snellen) or better

Exclusion Criteria:

* autoimmune diseases in the acute stage
* neurological and mental diseases
* diabetic retinopathy
* addictions
* hypertension (maximum 160/100 mmHg)
* retinitis pigmentosa-
* pathological nystagmus
* non-distant tumors or recurrent tumors
* photosensitivity
* pregnancy
* electric or electronic implants (e.g. heart pacemaker)
* metal implants in the eyes or head (with the exception of dental prosthesis or shunts)

+Locations (1)

Facility	City	Country	Status
Institute of Medical Psychology	Magdeburg	Germany

+Publications

Gall C, Schmidt S, Schittkowski MP, Antal A, Ambrus GG, Paulus W, Dannhauer M, Michalik R, Mante A, Bola M, Lux A, Kropf S, Brandt SA, Sabel BA. Alternating Current Stimulation for Vision Restoration after Optic Nerve Damage: A Randomized Clinical Trial. PLoS One. 2016 Jun 29;11(6):e0156134. doi: 10.1371/journal.pone.0156134. eCollection 2016. PMID 27355577