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Behavioural Intervention

Brain Stimulation for Convergence Insufficiency (NIBSCI Trial)

N/A

Recruiting

Research Sponsored by Midwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

Awards & highlights

NIBSCI Trial Summary

This trial will test if non-invasive brain stimulation can shorten treatment time & be as effective as office-based vergence/accommodative therapy for convergence insufficiency. Participants will be randomized into 3 treatment groups & researchers will compare pre- & post-treatment measurements.

Who is the study for?

Adults with symptomatic convergence insufficiency, specifically those who have a receded near point of convergence, insufficient positive fusional vergence at near, and a certain score on the CISS test. Participants must not have had previous treatments for this condition, no history of constant strabismus or surgery for it, and should not be affected by systemic diseases that impact eye function.Check my eligibility

What is being tested?

The trial is testing if non-invasive brain stimulation can reduce treatment time from 12 to 8 weeks when combined with office-based therapy for eye disorders or if it's as effective alone. It involves comparing three groups: one receiving both therapies, one with sham stimulation plus therapy, and one with only the brain stimulation.See study design

What are the potential side effects?

Potential side effects may include discomfort at the stimulation site on the scalp, mild headaches or tingling during transcranial direct current stimulation (tDCS), fatigue after sessions. Sham tDCS should have no active side effects but may cause similar sensations due to placebo effect.

NIBSCI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks, 6 weeks, and 8 weeks during treatment; 6 months and 12 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Near Point of Convergence (NPC)

Positive Fusional Vergence (PFV)

Secondary outcome measures

Convergence Insufficiency Symptoms Survey (CISS)

NIBSCI Trial Design

3Treatment groups

Active Control

Placebo Group

Group I: NIBS-OBVATActive Control2 Interventions

8 sessions of non-invasive brain stimulation with 8 weeks of office-based vergence/accommodative therapy.

Group II: NIBSActive Control1 Intervention

8 sessions of non-invasive brain stimulation only.

Group III: OBVATPlacebo Group2 Interventions

8 sessions of sham stimulation with 8 weeks of office-based vergence/accommodative therapy.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

New Jersey Institute of TechnologyOTHER

8 Previous Clinical Trials

793 Total Patients Enrolled

4 Trials studying Convergence Insufficiency

514 Patients Enrolled for Convergence Insufficiency

University of Waterloo School of Optometry and Vision ScienceUNKNOWN

Midwestern UniversityLead Sponsor

18 Previous Clinical Trials

3,254 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible to still join this experiment?

"Clinicaltrials.gov reveals that this investigation is still actively recruiting participants, having been posted on the 1st of November 2023 and last edited 18th October of the same year."

Answered by AI

How many participants have joined this research endeavor?

"Affirmative. Information available on clinicaltrials.gov elucidates that this medical trial is actively seeking participants, which was initially advertised on November 1st 2023 and recently updated October 18th 2023. A total of 150 patients are needed across one site for the study to be conducted."

Answered by AI

Does this experiment accept elderly participants?

"This trial is exclusively for patients aged 18 to 40. However, there are alternative clinical trials available for minors and geriatrics in need of the same treatment. Specifically, 6 studies have been established for those under 18 and 3 designed specifically with seniors in mind."

Answered by AI

Can I participate in this research endeavor?

"This trial is seeking 150 individuals with convergence insufficiency, between 18 and 40 years old. Vital criteria include: 20/25 best-corrected visual acuity in each eye at a distance or near, exophoria which exceeds 4∆ further at near than far points, receded point of convergence greater than 6 cm break, insufficient positive fusional vergence (< 15∆ base-out blur or break), CISS score of 16+ for children and 21+ for adults, recent dilated fundus examination within one year prior to participation, signed informed consent forms from participants willing to be randomized."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency

Arijit Chakraborty 2023. "Non-invasive Brain Stimulation for Treating Symptomatic Convergence Insufficiency". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05877560.