Evaluation on Visual Outcome of TMS | NCT06612190

Studies
Evaluation on Visual Outcome of TMS

NCT06612190

Sponsor

Evidence Based Cataract Study Group

Status

Not yet recruiting

Last Update Posted

Sep 25, 2024Actual

Enrollment

300Estimated

Phase

Not Applicable

Conditions

Visual Impairment

Interventions

TMS
Control

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2024Estimated

Primary Completion Date

Oct 2025Estimated

Completion Date

Oct 2027Estimated

First Submitted Date

Sep 21, 2024

First Submission Date that Met QC Criteria

Sep 21, 2024

First Posted Date

Sep 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2024

Last Update Posted Date

Sep 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this clinical trial is to learn if transcranial magnetic stimulation (TMS) can improve the visual outcomes in patients with visual impairment. The main question it aims to answer is:

• Does TMS improve the visual outcome in patients who suffer from visual impairment? Researchers will compare TMS to the control group who will not receive effective TMS treatment) to see if TMS works to improve the visual outcomes of the patients.

Participants will

Undergo TMS treatment or no effective TMS for consecutive 5 days.
Visit the clinic once every 2 weeks for checkups and tests.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TMS	Experimental		Procedure: TMS
Control	Sham Comparator		Procedure: Control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TMS	Procedure	TMS treatment in this study indicates a non-invasive procedure called transcranial magnetic simulation (TMS) on visual cortex. The treatment intensity is set as 80% of the threshold of each participant. The treatment will be conducted every day for consecutive 5 days.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Visual acuity		From enrollment to the end of treatment at 6 months

Secondary Outcomes

Measure	Description	Time Frame
Visual field		From enrollment to the end of treatment at 6 months

Other Outcomes

Measure	Description	Time Frame
Visual quality	Include objective visual quality (contrast sensitivity) and subjective visual quality (visual function questionnaire score).	From enrollment to the end of treatment at 6 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Post cataract surgery or clear lens
Best-corrected visual acuity less than 0.1logMAR

Exclusion Criteria:

Diagnosed with cognitive impairment or mental disorders and unable to cooperate with treatment;
Diagnosed with ocular diseases that affect observation of visual function;
History of epileptic seizures;
Long term use of psychotropic drugs；
Metal implants in the body.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

80 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Xiangjia Zhu	Contact	0086+02164377134		zhuxiangjia1982@126.com

Overall Officials

Name	Affiliation	Role
Xiangjia Zhu	Eye and ENT Hospital of Fudan University	Study Chair
Yating Tang	Eye and ENT Hospital of Fudan University	Principal Investigator
Yinglei Zhang

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Eye and Ear, Nose Throat Hospital of Fudan University		Shanghai	Shanghai Municipality	200031	China

Condition Browse Module

MeSH Terms

ID	Term
D014786	Vision Disorders

Ancestor Terms

ID	Term
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

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