Clinical Study of Structural and Functional Evaluation of the Visual Pathway

NCT ID: NCT03591315

Last Updated: 2018-07-23

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-07-31
• Study Completion Date: 2019-01-31

Brief Summary

Sellar area tumors such as pituitary adenoma, craniopharyngioma and meningioma, etc, commonly lead to visual impairment symptoms. Patients suffer from a loss of visual acuity (VA) and visual field defects (VF) due to a local compression on the optic chiasma by the tumor. In the management of these patients, it is an important goal to evaluate their visual function throughout the treatment, so as to predict the outcome of the visual function .

Since the visual pathway contains a huge complex network of both structure and function, traditional simplex evaluation of VA and VF is obviously not enough. Former studies have revealed changes in the visual network and cortex structure in neurodegenerative diseases and optic neuritis, yet the functional and structural changes caused by local tumor compression and their relation to the visual cortex activity patterns needs further research.

The objective of this research is to asses the visual function in patients with sellar area tumor 1 week preoperatively (baseline),72 hours postoperatively(checking point 1) and at 3 months follow up(checkpoint 2). By using multimodal evaluation including visual resting and task state fMRI, diffusion tensor imaging (DTI), etc. The investigators aim to reveal the changes in functional connectivity (FC), amplitude of low frequency fluctuation (ALFF), regional homogeneity (REHO) ,visual cortex activity patterns and tract-based spatial statistics (TBSS).

Detailed Description

Detailed Description:

Study objective

Visual pathway contains both structural and functional network. When it is impacted by neurodegenerative diseases, neuritis or direct mechanical pressure, visual impairment occurs due to damage to the pathway. Former study on Parkinson's disease (Dagmar H. Heep et al, Radiology, 2017 ) found loss of functional connectivity in posterior and paracentral brain regions, while a study on optic neuritis (Yael Backner et al, JAMA Neurology,2018) showed an increase in functional connectivity and slightly loss in optic fiber integrity. Instead of simplex resting-state fMRI，the investigators of this study aim to assess:

1. whether similar changes in functional networking occur when visual pathway is impacted by chiasma compression from tumors in sellar area (by resting-state fMRI).

2. The correlation between local chiasma compression and visual cortex activation pattern ( by visual tasking-state fMRI).

3. Changes and recovery of the white matter fiber structure in the visual pathway.

( by diffusion tensor imaging, DTI).

Method Participants: 60 adult participants (18-60 years old ) will be enrolled in the department of Neurosurgery at Xiangya Hospital of Central South University. The experimental arm will consist of 30 patients with visual impairment symptoms caused by chiasma compression by sellar area tumors (Tumor Group, TG). The control arm will consist of 30 healthy controls without any nervous system disease or visual impairment (Healthy Control Group, HC, control arm).

Study design: Transversal and Longitudinal, single center, comparative study is designed to evaluate functional and structural visual networking of sellar area tumor patients and healthy controls. The study involves assessment with resting-state fMRI, tasking-state fMRI and DTI. Patients of experimental arm will be evaluated by multimodal fMRI at 3 different checkpoints (baseline is 1 week preoperative ,checkpoint 1 is 72 hours postoperative ,checkpoint 2 is 3 months follow up ). Participants of control arm will be evaluated only once. Transversal comparison will be conducted between preoperative tumor patients and healthy controls, while longitudinal comparison will be within tumor group at baseline and two other different checkpoints.

MRI data acquisition and analysis strategy: In this study, the MRI data is acquired by Siemens 3.0T Prisma scanner, including sequences of mprage T1 , diffusion tensor imaging, resting-state fMRI and visual stimulation task fMRI. Resting-state fMRI longitudinal data analysis includes functional connectivity (FC), amplitude of low frequency fluctuation (ALFF) and regional homogeneity (REHO) to assess visual functional networking in both group. These Data wil be analysed using a multivariate approach and independent component analysis (ICA). Visual tasking fMRI will be conducted under classic black and white "chess board" simulation on each eye. For the evaluation of structural visual network, afferent visual pathway (optic tract and radiation ), fiber tracking as well as tract-based spatial statistics (TBSS) will be analyzed within both arms at baseline,checkpoint 1 and checkpoint 2 of the experimental arm will verify changing and recovering process of the visual pathway after chiasma decompression.

Primary outcomes

1. The difference in visual pathway anatomy and functional network between preoperative sellar area tumor patients and healthy controls. Tumor patients will be evaluated clinically by visual acuity (VA), visual field (VF), tumor height and chiasma thickness.

2. The verification of the correlation between patterns of chiasma compression and visual cortex activity. Revealing the difference of visual cortex activity patterns between both arms.

Secondary outcomes Throughout the 3 months follow up of the experimental arm patients, observe and verify the recovery process of both functional and structural visual network after chiasma decompression and evaluate its correlation with clinical visual function outcome.

Statistics

1. An analysis of two sample T test between the two groups will be performed to assess the difference of FC,REHO,ALFF and visual cortex activity pattern between resting state data and data from the visual task of TG and HC.

2. An analysis of variance (ANOVA) within TG group will be performed to assess the changes and recovery of FC, REHO, ALFF and visual cortex activity pattern via resting state data and data from the visual task's data.

Correlations will be explored between multimodal fMRI parameters (both functional and structural) and clinical criteria (e.g VA,VF, tumor size, visual outcome, etc).

Conditions

Pituitary Adenoma; Visual Impairment; Sellar Tumor; Neuroimaging

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

TG group

Patients with visual impairment caused by chiasma compression from sellar area tumors will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.

resting state fMRI

Intervention Type: DIAGNOSTIC_TEST

Define the visual resting state network.

visual tasking state fMRI

Intervention Type: DIAGNOSTIC_TEST

Using visual task stimulation to identify the activation characteristic of primary visual cortex.

diffusion tensor imaging

Intervention Type: DIAGNOSTIC_TEST

Define the integrity of white matter fibers in the visual pathway.

automated visual field

Intervention Type: DIAGNOSTIC_TEST

Identify the existence and type of visual field defect.

visual acuity

Intervention Type: DIAGNOSTIC_TEST

Assess the visual acuity by using ETDRS scales.

HC group

Volunteers with no visual impairment(visual acuity of both eyes \>1.0) or Nervous System disease will undergo the following examinations: resting state fMRI, visual tasking state fMRI, diffusion tensor imaging (DTI), visual acuity and automated visual field test.

resting state fMRI

Intervention Type: DIAGNOSTIC_TEST

Define the visual resting state network.

visual tasking state fMRI

Intervention Type: DIAGNOSTIC_TEST

Using visual task stimulation to identify the activation characteristic of primary visual cortex.

diffusion tensor imaging

Intervention Type: DIAGNOSTIC_TEST

Define the integrity of white matter fibers in the visual pathway.

automated visual field

Intervention Type: DIAGNOSTIC_TEST

Identify the existence and type of visual field defect.

visual acuity

Intervention Type: DIAGNOSTIC_TEST

Assess the visual acuity by using ETDRS scales.

Interventions

resting state fMRI

Define the visual resting state network.

Intervention Type: DIAGNOSTIC_TEST

visual tasking state fMRI

Using visual task stimulation to identify the activation characteristic of primary visual cortex.

Intervention Type: DIAGNOSTIC_TEST

diffusion tensor imaging

Define the integrity of white matter fibers in the visual pathway.

Intervention Type: DIAGNOSTIC_TEST

automated visual field

Identify the existence and type of visual field defect.

Intervention Type: DIAGNOSTIC_TEST

visual acuity

Assess the visual acuity by using ETDRS scales.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

V-RS; DTI; VF; VA

Eligibility Criteria

Inclusion Criteria

1. patients with sellar area tumors ( including pituitary adenoma,craniopharyngioma and meningioma) resulting a visual deficit (loss of visual acuity or visual field).

2. Male or female between 18y to 60y.

3. Patients treated with transsphenoidal surgery.

4. Patients agreeing to participate in the study and willing to sign an informed consent.

Exclusion Criteria

1. tumor height ≥ 4cm.

2. Patients with recurrent tumors, previous craniotomy or gamma knife treatment

3. Visual impairment caused by other diseases.

4. Mental disorders, inability to cooperate with treatment and follow up visits.

5. Patients with other serious complications.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Xiangya Hospital of Central South University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liu Z Xiong, MD/PhD

Role: STUDY_CHAIR

Neurosurgery department, Xiangya Hospital of Central South University, Changsha, Hunan, China

Locations

Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Central Contacts

Liu Z Xiong, MD/PhD

Role: CONTACT

zhixiongliu@csu.edu.cn

13607318785

Zhong W Ming, MD

Role: CONTACT

sjwkkarl@163.com

18874002961

Facility Contacts

Liu Z Xiong, MD/PhD

Role: primary

zhixiongliu@csu.edu.cn

13607318785

References

Backner Y, Kuchling J, Massarwa S, Oberwahrenbrock T, Finke C, Bellmann-Strobl J, Ruprecht K, Brandt AU, Zimmermann H, Raz N, Paul F, Levin N. Anatomical Wiring and Functional Networking Changes in the Visual System Following Optic Neuritis. JAMA Neurol. 2018 Mar 1;75(3):287-295. doi: 10.1001/jamaneurol.2017.3880.

Reference Type: RESULT

PMID: 29297053 (View on PubMed)

Hepp DH, Foncke EMJ, Olde Dubbelink KTE, van de Berg WDJ, Berendse HW, Schoonheim MM. Loss of Functional Connectivity in Patients with Parkinson Disease and Visual Hallucinations. Radiology. 2017 Dec;285(3):896-903. doi: 10.1148/radiol.2017170438. Epub 2017 Sep 27.

Reference Type: RESULT

PMID: 28952907 (View on PubMed)

Other Identifiers

201611627

Identifier Type: -

Identifier Source: org_study_id