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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04010994
Other study ID # StimulationMagd
Secondary ID
Status Enrolling by invitation
Phase Phase 1/Phase 2
First received
Last updated
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
Health authority
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)

Study Design


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
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