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Role of Ketogenic Diet in SSPE

Studies

Study First Submitted Date 2021-11-03
Study First Posted Date 2021-12-10
Last Update Posted Date 2023-07-25
Start Month Year January 2024
Primary Completion Month Year December 2025
Verification Month Year July 2023
Verification Date 2023-07-31
Last Update Posted Date 2023-07-25

Detailed Descriptions

Sequence: 20753769
Description Methodology This will be a bi-center trial. The national institute of child health (NICH) will be a partner in this study along with Aga Khan University Hospital, Karachi. This study will be a nutritional research study looking at the role of the Ketogenic diet in improving seizures and overall disability in children with SSPE. LGIT will be the form of KD used for these patients. All families with children who have been newly diagnosed with confirmed SSPE will be approached to start the low glycemic index diet,(liberalized kind of KD). They will be counseled on the disease and the diet regimen. all possible side effects and management will be discussed. The duration of follow-up will be for one year and there will be no potential cost incurred by the patient. Patients will also be followed up by the physiotherapist at the physiotherapy department at AKU ( @ no cost)who will be supporting their motor rehabilitation. Investigations which include blood work and echo and ultrasound and EEGs will be done at regular intervals Sampling technique A consecutive sampling of all children who are diagnosed with SSPE will be used. A total of 26 children >2-<15 years will be enrolled over a period of two years.

Conditions

Sequence: 52253280
Name SSPE
Downcase Name sspe

Id Information

Sequence: 40218500
Id Source org_study_id
Id Value 2021-6491-19410.

Design Groups

Sequence: 55685216
Group Type Other
Title Ketogenic Diet
Description This will be a prospective cohort study. All families with children who have been newly diagnosed with confirmed SSPE (based on Dyken's Criteria) will be approached to start the low glycemic index diet (liberalized kind of KD). A thorough dietary history will be taken from the parents/caregivers, and they will be counseled by a trained dietitian on the diet, all pros and cons, and the format. After the verbal agreement, formal consent will be taken from the parent/ caregiver for initiation of the diet.

Interventions

Sequence: 52566151
Intervention Type Other
Name KETOGENIC DIET
Description This will be a prospective cohort study. All families with children who have been newly diagnosed with confirmed SSPE (based on Dyken's Criteria) will be approached to start the low glycemic index diet (liberalized kind of KD). A thorough dietary history will be taken from the parents/caregivers, and they will be counseled by a trained dietitian on the diet, all pros and cons, and the format. After the verbal agreement, formal consent will be taken from the parent/ caregiver for initiation of the diet. These patients are usually already admitted in the hospital for initial diagnosis and management. Therefore the initiation of the diet will be in the hospital during their admission if the parents/ caregivers agrees. A minimum of 2-3 days would be required to train the parents/caregivers.

Keywords

Sequence: 79984996 Sequence: 79984997 Sequence: 79984998
Name Ketogenic Diet Name Progressive Neurological Disorder Name Intractable Epilepsy
Downcase Name ketogenic diet Downcase Name progressive neurological disorder Downcase Name intractable epilepsy

Design Outcomes

Sequence: 177680388 Sequence: 177680389 Sequence: 177680390 Sequence: 177680391
Outcome Type primary Outcome Type secondary Outcome Type secondary Outcome Type secondary
Measure Seizure control Measure cognitive Change , Measure behavioral Change Measure motor developmental Change
Time Frame for a period of 6 months . Time Frame base line, after 6 months of study then after and one year of study. Time Frame base line, after 6 months of study then after and one year of study Time Frame base line, after 6 months of study then after and one year of study
Description frequency and severity will be measured through a seizure record diary, daily number of seziures will be averaged over a month and monthly record will be evaluated as percentage increase or decrease in 3 months intervals Description checked by using Pedicat with 4 domains. Daily activities, Mobility and Social/Cognitive domains.The three functional skill domains are rated on a 4 point scale: Unable Hard A little hard Easy 0.I don't know Responsibility:This domain has its own 5 point scale: Adult/caregiver has full responsibility; Adult/caregiver has most responsibility and child takes a little responsibility Adult/caregiver and child share responsibility about equally Child has most responsibility with a little direction, supervision or guidance from an adult/caregiver Child takes full responsibility without any direction, supervision or guidance from an adult/caregiver Two types of score will calculate: normative scores and scaled scores. The normative score is based on the child's chronological age. Scaled score provides a way to look at current functional skills and progress in skills over times (compare the child towards itself). Description this will be checked by using modified Ashworth scales.MODIFIED ASHWORTH The modified Ashworth scale is a muscle tone assessment scale used to assess the resistance experienced during passive range of motion, which does not require any instrumentation and is quick to perform. scoring 0 No increase in tone 1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension. 1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension Description this will be checked by , Modified Rankin and GMFM Modified Rankin Scale Score Description 0 No symptoms at all No significant disability despite symptoms Slight disability Moderate disability Moderately severe disability Severe disability Dead GMFM There is a scoring system with each item scored as 0, 1, 2, 3, or "not tested". A scoring key of 0 – does not initiate, 1 – initiates, 2 – partially completes, and 3 – completed, is used; however parameters such as distance, time, support provided, accuracy, counts, and tasks will determine specific item scores. Items that a child refuses to attempt despite reason they may be able to perform at least partially or items not administered are scored as 'not tested'. The scoring system of the GMFM is a four-point scale that consists of 66 items divided into five dimensions of gross motor function:(a) lying and rolling, (b) sitting, (c) crawling and kneeling, (d) standing, and (e) walking, running and jumping.

Browse Conditions

Sequence: 193800727 Sequence: 193800728 Sequence: 193800729 Sequence: 193800730 Sequence: 193800731 Sequence: 193800732 Sequence: 193800733 Sequence: 193800734 Sequence: 193800735 Sequence: 193800736 Sequence: 193800737 Sequence: 193800738 Sequence: 193800739 Sequence: 193800740 Sequence: 193800741 Sequence: 193800742 Sequence: 193800743 Sequence: 193800744
Mesh Term Subacute Sclerosing Panencephalitis Mesh Term Encephalitis, Viral Mesh Term Central Nervous System Viral Diseases Mesh Term Central Nervous System Infections Mesh Term Infections Mesh Term Infectious Encephalitis Mesh Term Virus Diseases Mesh Term Measles Mesh Term Morbillivirus Infections Mesh Term Paramyxoviridae Infections Mesh Term Mononegavirales Infections Mesh Term RNA Virus Infections Mesh Term Slow Virus Diseases Mesh Term Encephalitis Mesh Term Brain Diseases Mesh Term Central Nervous System Diseases Mesh Term Nervous System Diseases Mesh Term Neuroinflammatory Diseases
Downcase Mesh Term subacute sclerosing panencephalitis Downcase Mesh Term encephalitis, viral Downcase Mesh Term central nervous system viral diseases Downcase Mesh Term central nervous system infections Downcase Mesh Term infections Downcase Mesh Term infectious encephalitis Downcase Mesh Term virus diseases Downcase Mesh Term measles Downcase Mesh Term morbillivirus infections Downcase Mesh Term paramyxoviridae infections Downcase Mesh Term mononegavirales infections Downcase Mesh Term rna virus infections Downcase Mesh Term slow virus diseases Downcase Mesh Term encephalitis Downcase Mesh Term brain diseases Downcase Mesh Term central nervous system diseases Downcase Mesh Term nervous system diseases Downcase Mesh Term neuroinflammatory diseases
Mesh Type mesh-list Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor Mesh Type mesh-ancestor

Sponsors

Sequence: 48396314 Sequence: 48396315
Agency Class OTHER Agency Class OTHER_GOV
Lead Or Collaborator lead Lead Or Collaborator collaborator
Name Aga Khan University Name National Institute of Child Health, Karachi, Pakistan

Overall Officials

Sequence: 29329982
Role Principal Investigator
Name Shahnaz H Ibrahim, MBBS ;FCPS
Affiliation AKU

Central Contacts

Sequence: 12028207 Sequence: 12028208
Contact Type primary Contact Type backup
Name Shahnaz H Ibrahim, MBBS;FCPS Name Hira Farooq, NUTRITION
Phone +923002119347 Phone +923152566548
Email shahnaz.ibrahim@aku.edu Email hira.farooq@aku.edu
Role Contact Role Contact

Design Group Interventions

Sequence: 68260049
Design Group Id 55685216
Intervention Id 52566151

Eligibilities

Sequence: 30813248
Gender All
Minimum Age 2 Years
Maximum Age 15 Years
Healthy Volunteers No
Criteria Inclusion Criteria:• All patients with a recent diagnosis of SSPE based on Dyken's criteria. Children aged ≥2 – ≤15 years. • Having at least one member of the family residing with the patient who can read and understand directions in Urdu and /or Sindhi. Exclusion Criteria: • Parents not agreeing to start the diet. Age less than 2 years or over 15 years. Patients who are already being given immune modulators. Any other associated co-morbidity. Patients having difficulty in swallowing and parents not allowing a nasogastric tube. Totally uneducated family with no one who can read or write and understand directions in Urdu and/ or Sindhi.
Adult False
Child True
Older Adult False

Calculated Values

Sequence: 254062501
Registered In Calendar Year 2021
Were Results Reported False
Has Single Facility False
Minimum Age Num 2
Maximum Age Num 15
Minimum Age Unit Years
Maximum Age Unit Years
Number Of Primary Outcomes To Measure 1
Number Of Secondary Outcomes To Measure 3

Designs

Sequence: 30559217
Allocation N/A
Intervention Model Single Group Assignment
Observational Model
Primary Purpose Treatment
Time Perspective
Masking None (Open Label)

Intervention Other Names

Sequence: 26711422
Intervention Id 52566151
Name LOW GLYCEMIC INDEX DIET

Links

Sequence: 4394493
Url http://doi.org/10.2147/PHMT.S126293
Description Jafri SK, Kumar R, Ibrahim SH. Subacute sclerosing panencephalitis – current perspectives. Pediatric Health Med Ther. 2018;9:67-71

Responsible Parties

Sequence: 28925614
Responsible Party Type Principal Investigator
Name Dr Shahnaz Ibrahim
Title PROFESSOR
Affiliation Aga Khan University

Study References

Sequence: 52152372 Sequence: 52152373
Pmid 25149833 Pmid 25232151
Reference Type result Reference Type result
Citation Rafique A, Amjad N, Chand P, Zaidi SS, Rana MS, Ahmed K, Ibrahim S. Subacute sclerosing panencephalitis: clinical and demographic characteristics. J Coll Physicians Surg Pak. 2014 Aug;24(8):557-60. Citation Ibrahim SH, Amjad N, Saleem AF, Chand P, Rafique A, Humayun KN. The upsurge of SSPE–a reflection of national measles immunization status in Pakistan. J Trop Pediatr. 2014 Dec;60(6):449-53. doi: 10.1093/tropej/fmu050. Epub 2014 Sep 16.