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Radiotracer study of the brains glymphatic system

Glymphatic system clearance of a radiotracer in patients with craniectomy and dementia: A prospective pilot study - NIL

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/09/057863
Enrollment
10
Registered
2023-09-20
Start date
Unknown
Completion date
Unknown
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G319- Degenerative disease of nervous system, unspecified Health Condition 2: G318- Other specified degenerative diseases of nervous system

Interventions

Intervention1: Intrathecal Technetium-99m Diethylenetriamine pentaacetate injection: We will inject five millicurie (volume of 0.5 ml) activity of Technetium-99m Diethylenetriamine pentaacetate (99mT

Sponsors

Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)
Lead Sponsor

Eligibility

Inclusion criteria

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: 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.

Design outcomes

Primary

MeasureTime frame
Find the pattern of SPECT-detected radiotracer distribution in patients with decompressive craniectomy and dementia. Timepoint: 24 hours after the injection

Secondary

MeasureTime frame
ee if the urinary excretion data vary significantly after cranioplasty in patients with craniectomy defects. Timepoint: Three months;Get the urinary excretion data in this group of patients 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? Timepoint: 24 hours after the injection;Is there demonstrable lymph node uptake after spinal subarachnoid injection of the radiotracer? Timepoint: 24 hours after the injection

Countries

India

Contacts

Public ContactGopalakrishnan Madhavan Sasidharan

Jawaharlal Institute of Post-graduate Medical Education and Research (JIPMER)

gopalakrishnanms@gmail.com09442587797

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026