GlaucomaPhase 1/2HomeStimNCT04010994
Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation
A Phase 1/2 study testing Transorbital electrical stimulation in people with Glaucoma and Electrical Stimulation, run by University of Magdeburg at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma, Electrical Stimulation, Home Treatment
- What is being tested?
- Transorbital electrical stimulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 5 Aug 2019to 31 Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- autoimmune diseases in the acute stage
- neurological and mental diseases
- diabetic retinopathy
- addictions
- hypertension (maximum 160/100 mmHg)
- retinitis pigmentosa-
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
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.
- Conditions
- Glaucoma, Electrical Stimulation, Home Treatment
- Being tested
- Transorbital electrical stimulation
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transorbital electrical stimulationProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| rtACS | Other | repetitive transorbital ACS Receives: Procedure: Transorbital electrical stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual field size
Static perimetry and high resolution perimetry will be used to measure the visual field sizes
Measured: 3 months
Secondary outcomes (2)
EEG connectivities in the visual system
EEG recordings will be done using 128 channels, power spectra will be determined
Measured: 3 months
Level of vascular regulation/dysregulation in the eye
Dynamic vessel analysis will be used the measure blood flow in the eye
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2019
- Study start5 Aug 2019
- Primary completion30 Jul 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bernhard A. Sabel, University of Magdeburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04010994
- Sponsor's protocol ID
- StimulationMagd
- Acronym
- HomeStim
- Status last verified
- Oct 2019
- First submitted
- 3 Jul 2019
- Last updated
- 3 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available without restriction
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.
PubMed 27355577
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Optic Nerve Damage Patients Using Electrostimulation: a Home Stimulation Study
- ClinicalTrials.gov ID
- NCT04010994
- Acronym / sponsor ID
- HomeStim / StimulationMagd
- Conditions
- Glaucoma, Electrical Stimulation, Home Treatment
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- 5 Aug 2019 (actual)
- Primary completion
- 30 Jul 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 8 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| rtACS | Other | Procedure: Transorbital electrical stimulationrepetitive transorbital ACS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- autoimmune diseases in the acute stage
- neurological and mental diseases
- diabetic retinopathy
- addictions
- hypertension (maximum 160/100 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transorbital electrical stimulationTransorbital 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 | Procedure or surgery | rtACS |
Primary outcome
Visual field size
Time frame: 3 months
Static perimetry and high resolution perimetry will be used to measure the visual field sizes
2 secondary outcomes
EEG connectivities in the visual system
Time frame: 3 months
Level of vascular regulation/dysregulation in the eye
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2019.
- Background: PubMed 27355577Gall 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.
- Individual participant dataSharing planned: Yes. Data will be available without restriction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Transorbital electrical stimulation in people with Glaucoma and Electrical Stimulation, run by University of Magdeburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual field size (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04010994, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2019.