Targeted Shortwave Diathermy Combined With Perceptual Training for Patients With Severe Traumatic Optic Neuropathy

NCT05140486 | Unknown DMC

• 1 other identifier: HunanPPH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose: Patients with severe traumatic optic neuropathy (TON) have limited improvement in visual function despite therapy. The hypothesis of the study is that the targeted shortwave diathermy combined with perceptual training may enhance visual function in patients with severe TON after endoscopic optic nerve decompression (EOND) surgery. Design: Clinical trial Subjects: Twenty-two subjects with severe TON after EOND surgery were randomly assigned to either a rehabilitation (Reh) group or nonrehabilitation (Nreh) group. Methods: High-resolution computed tomography and MRI were used to locate the impaired nerve. The subjects in the Reh group received targeted shortwave diathermy therapy 5 days per week for 4 weeks and perceptual training 5 days per week for 10 weeks. Main Outcome Measures: A thorough evaluation of visual function, visual evoked potential, and diffusion tensor imaging was executed.

Conditions

Traumatic Optic Neuropathy

Keywords

Shortwave diathermy; perceptual training; traumatic optic neuropathy

Outcome Measures

Primary Outcomes (2)

• MRI

  A 32-channel head coil on a 3.0T MRI system (Philips, Ltd, Best, the Netherlands) was used for the acquisition of imaging data. T1- and T2-weighted, fat-suppressed images were obtained axially through the orbit and some parts of the brain, including the intracranial portion of the optic nerve, postoperatively and 10 weeks after rehabilitation.

  15 minutes

• Diffusion tensor imaging

  Optic nerve diffusion tensor imaging images were obtained using single-shot echoplanar imaging sequences. The images were acquired from the optic papilla to the orbital apex of the optic nerve with 40 contiguous slices. The region of interest was manually manually placed over the optic nerve at the anterior, middle, and posterior segments on the non-diffusion-weighted image. The fraction anisotropy, mean diffusivity, axial diffusivity, and radial diffusivity of optic nerves were measured.

  15 minutes

Secondary Outcomes (3)

• Visual evoked potential

  30 minutes

• Best-corrected visual acuity

  5 minutes

• Color vision

  5 minutes

Study Arms (2)

Shortwave diathermy and perceptual training

EXPERIMENTAL

The subjects in this group will receive shortwave diathermy 5 days per week for 4 weeks and perceptual training 5 days per week for 10 weeks after endoscopic optic nerve decompression surgery.

Procedure: Rehabilitation: shortwave diathermy and perceptual training

Nonrehabilitation

NO INTERVENTION

The subjects in the nonrehabilitation group will not only receive any rehabilitation therapy after endoscopic optic nerve decompression surgery.

Interventions

Rehabilitation: shortwave diathermy and perceptual training PROCEDURE

All subjects in the rehabilitation group received shortwave diathermy therapy 5 days per week for 4 weeks and perceptual training 5 days per week for 10 weeks.

Shortwave diathermy and perceptual training

Eligibility Criteria

• Age: 3 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• The indications for endoscopic optic nerve decompression surgery included no improvement after intravenous treatment for 24 hours, no evidence of injury in the intracranial portion of the optic nerve, and the presence of bony fragments or hematoma compressing the optic nerve.
• TON with best-corrected visual acuity equal to or more than 1.85 logMAR after surgery was considered as severe TON, and those patients managed with endoscopic optic nerve decompression surgery were recruited in this study.
• Eligible criteria for the participants were as follows: (1) not receiving other physical therapy regimens aside from this intervention; (2) age 3 to 60 years old; (3) ability to execute simple verbal instructions; (4) not being delirious; (5) having stable vital signs and medical conditions.

Sponsors & Collaborators

• Hunan Provincial People's Hospital: lead

Study Sites (1)

Tang

Changsha, 410008, China

RECRUITING

MeSH Terms

Conditions

Optic Nerve Injuries

Condition Hierarchy (Ancestors)

Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases; Wounds and Injuries

Study Officials

• XiaoYe Wang

  Brain Hospital of Hunan Province, Hunan University of Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Qingping Tang

CONTACT

+86-073185232387; tqingping111@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: December 1, 2021
• Study Start: January 20, 2017
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: December 1, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)