Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation

Glaucoma Clinical Trial

— HomeStim  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04010994
• Other study ID #: StimulationMagd
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: August 5, 2019
• Est. completion date: December 31, 2020

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: December 31, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Electrical Stimulation
• Glaucoma
• Home Treatment
• Optic Nerve Injuries

Intervention

Procedure:
• Transorbital electrical stimulation
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

Locations

Country	Name	City	State
Germany	Institute of Medical Psychology	Magdeburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Magdeburg

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual field size	Static perimetry and high resolution perimetry will be used to measure the visual field sizes	3 months
Secondary	EEG connectivities in the visual system	EEG recordings will be done using 128 channels, power spectra will be determined	3 months
Secondary	Level of vascular regulation/dysregulation in the eye	Dynamic vessel analysis will be used the measure blood flow in the eye	3 months