Clinical trial NCT05152771: Role of Ketogenic Diet in SSPE
Official title: Post Measles Subacute Sclerosing Panencephalitis (SSPE)and the Role of Ketogenic Diet, A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: SSPE
Keywords: Ketogenic Diet
Progressive Neurological Disorder
Intractable Epilepsy
Lead sponsor: Aga Khan University
Sponsor class: OTHER
Collaborators: name: National Institute of Child Health, Karachi, Pakistan
First posted: 2021-12-10
Enrollment: 26
Sex: ALL
Minimum age (years): 2
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: SSPE is a progressive neurodegenerative disorder occurring after measles infection and is potentially life-threatening.Measles infection remains endemic in Pakistan especially in the lower socioeconomic population where the vaccine coverage is low. The ketogenic diet has been used in a large number of diseases especially intractable epilepsies in children and also in certain neurodegenerative disorders like Parkinson's and Alzheimer's in adults. Some of the case reports from India and the USA have reported the beneficial results of ketogenic diet(KD) not only in the control of myoclonic jerks of SSPE but also in stopping and reversing the progress of the disease. There is a definite need to conduct a multi-center trial of KD to establish its effectiveness in SSPE.

At the Aga khan university, the investigators have an experienced team who have been using KD for the last 9 years for intractable epilepsy. At AKU the investigators currently have 4 patients on board for the past 4 months, with diagnosed SSPE on Low Glycemic Index Diet and showing some improvement in their seizure and motor control. Based on these reports, for a poor measles control country like Pakistan, there is a need to work further in order to establish evidence for KD therapy as a treatment for SSPE. The findings of the proposed study will serve as a hope for the improvement of quality of life of patients suffering from SSPE which is a devastating disease with almost 100% mortality .

Detailed 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.

Eligibility 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.

Primary outcomes:
measure: Seizure control
timeFrame: for a period of 6 months .
Secondary outcomes:
measure: cognitive Change ,
timeFrame: base line, after 6 months of study then after and one year of study.
measure: behavioral Change
timeFrame: base line, after 6 months of study then after and one year of study
measure: motor developmental Change
timeFrame: base line, after 6 months of study then after and one year of study
Other outcomes:
Locations:
Study officials:
affiliation: AKU
name: Shahnaz H Ibrahim, MBBS ;FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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.