Transcorneal Electrical Stimulation - Multicenter Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to expand the safety assessment of repeated applications of an electrical current from a DTL-like electrode in patients with RP.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Focused Ultrasound for Drug-resistant Epilepsy

NCT06292494

Focused Ultrasound MR-guided FUS Drug Refractory Epilepsy +2 more

RECRUITING NA

REC2Stim as a Treatment for Refractory Epilepsy in the Primary Sensorimotor Cortex.

NCT04158531

Epileptic Seizure Epilepsy Intractable Motor Seizure

UNKNOWN NA

Safety and Therapeutic Measures of Tdcs in Patients With Refractory Focal Epilepsy

NCT02866240

Refractory Epilepsy

COMPLETED NA

Pivotal-Safety and Therapeutic Measures of tDCS in Patients With Refractory Focal Epilepsy

NCT04770337

Refractory Epilepsy Focal Seizure Seizures, Focal +4 more

RECRUITING NA

Paraorbital-Occipital Electric Stimulation in Patients With Optic Neuropathy (BCT_optnerve)

NCT01282827

Visual Impairment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a single-arm open label interventional safety trial with RP patients, who receive weekly TES for 6 months on 1 eye followed by observation for another 6 months without stimulation. The primary outcome measure is safety, indicated by the frequency and severity of adverse events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Retinitis Pigmentosa

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OkuStim

Electrostimulation Standard Treatment with OkuStim

Group Type EXPERIMENTAL

Transcorneal electrostimulation

Intervention Type DEVICE

Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Transcorneal electrostimulation

Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OkuStim TES TcES

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients with retinitis pigmentosa (rod-cone dystrophy) after prescription of electrical stimulation by an ophthalmologist
* adult patients who are capable of giving consent,
* Visual acuity ≥ 0.02
* because the electrode is to be positioned on the eye at home, the patient or his family members should have sufficient fine motor skills (assessment by the study physician)
* the patient must be capable of giving consent and a medical assessment that he/she is able to participate in the whole study according to the protocol

Exclusion Criteria

* diabetic retinopathy
* neovascularisation of any origin
* after arterial or venous occlusion
* after retinal detachment
* silicone oil tamponade
* dry or exudative age-related macular degeneration
* macular edema
* all forms of glaucoma
* any form of corneal degeneration that reduces visual acuity
* systemic diseases that are difficult to control or manage, that could endanger the normal study schedule
* patients in a permanently poor general condition, which could hinder the regular attendance at control examinations in the clinic
* forms of mental illness related to the bipolar affective and schizoid-affective disorders, and all forms of dementia
* simultaneous participation in another interventional study or history of interventions whose effect may still persist

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No