MedPath

Radiotracer study of the brains glymphatic system

Phase 2
Conditions
Health Condition 1: G319- Degenerative disease of nervous system, unspecifiedHealth Condition 2: G318- Other specified degenerative diseases of nervous system
Registration Number
CTRI/2023/09/057863
Lead Sponsor
Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Yet Recruiting
Sex
Not specified
Target Recruitment
0
Inclusion Criteria

Decompressive craniectomy group

Adult (18 years or older) traumatic brain injury (TBI) patients who have undergone a decompressive craniectomy at least three months back.

Decompressive craniectomy has to have the largest dimension of 12 cm or more on CT scan

The brain under the craniectomy defect should not have gross damage, volume loss, or infarcts though some porencephalic changes due to previous head trauma are expected.

Adults with Probable dementia

Objective cognitive or behavioral impairment in at least two of the following Memory, Reasoning and handling complex tasks Visuospatial abilities, Language functions, Personality, behavior, or comportment

A decline from the previous level of functioning Functional impairment

Insidious onset and gradual progression

Initial symptoms

Amnestic

Nonamnestic (language, executive)

No other neurologic, psychiatric, or general medical disorders of severity that can interfere with cognition

Exclusion Criteria

Exclusion criteria for both groups:

Abnormal creatinine levels for the age group. The creatinine clearance should be normal as the urinary excretion data will be affected if the kidney function is abnormal.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Find the pattern of SPECT-detected radiotracer distribution in patients with decompressive craniectomy and dementia. <br/ ><br> <br/ ><br>Timepoint: 24 hours after the injection <br/ ><br>
Secondary Outcome Measures
NameTimeMethod
ee if the urinary excretion data vary significantly after cranioplasty in patients with craniectomy defects. <br/ ><br> <br/ ><br>Timepoint: Three months;Get the urinary excretion data in this group of patients <br/ ><br>Timepoint: 24 hours after the injection;Is there a difference in the lymph node uptake on the craniectomy side compared to that on the normal side? <br/ ><br>Timepoint: 24 hours after the injection;Is there demonstrable lymph node uptake after spinal subarachnoid injection of the radiotracer? <br/ ><br>Timepoint: 24 hours after the injection
© Copyright 2025. All Rights Reserved by MedPath