SSPENCT05152771
Role of Ketogenic Diet in SSPE
A study testing KETOGENIC DIET in people with SSPE, run by Aga Khan University.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 15 years
- Conditions the study is for
- SSPE
- What is being tested?
- KETOGENIC DIET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Jan 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- • 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Post Measles Subacute Sclerosing Panencephalitis (SSPE)and the Role of Ketogenic Diet, A Prospective Cohort Study
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 .
Read the 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.
- Conditions
- SSPE
- Being tested
- KETOGENIC DIET
- Keywords
- Ketogenic Diet, Progressive Neurological Disorder, Intractable Epilepsy
- Medical subject headings
- Subacute Sclerosing Panencephalitis, Drug Resistant Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KETOGENIC DIETOther
Also called LOW GLYCEMIC INDEX DIET
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.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic Diet | Other | 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. Receives: Other: KETOGENIC DIET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seizure control
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
Measured: for a period of 6 months .
Secondary outcomes (3)
cognitive Change ,
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).
Measured: base line, after 6 months of study then after and one year of study.
behavioral Change
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
Measured: base line, after 6 months of study then after and one year of study
motor developmental Change
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.
Measured: base line, after 6 months of study then after and one year of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SSPEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Child Health, Karachi, Pakistan
- Responsible party
- Principal investigator, Dr Shahnaz Ibrahim, Aga Khan University
- Investigators
- Shahnaz H Ibrahim, MBBS ;FCPS, Principal investigator, AKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152771
- Sponsor's protocol ID
- 2021-6491-19410.
- Status last verified
- Jul 2023
- First submitted
- 3 Nov 2021
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25149833Ibrahim 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.
PubMed 25232151
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Measles Subacute Sclerosing Panencephalitis (SSPE)and the Role of Ketogenic Diet, A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05152771
- Acronym / sponsor ID
- 2021-6491-19410.
- Conditions
- SSPE
- Keywords
- Ketogenic Diet, Progressive Neurological Disorder, Intractable Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Aga Khan UniversityUniversity, hospital or other
- Collaborators
- National Institute of Child Health, Karachi, Pakistan
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 10 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic Diet | Other | Other: KETOGENIC DIETThis 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. |
Who may qualify
- Ages
- 2 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- • Parents not agreeing to start the diet.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KETOGENIC DIETAlso: LOW GLYCEMIC INDEX DIETThis 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. | Other | Ketogenic Diet |
Primary outcome
Seizure control
Time frame: for a period of 6 months .
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
3 secondary outcomes
cognitive Change ,
Time frame: base line, after 6 months of study then after and one year of study.
behavioral Change
Time frame: base line, after 6 months of study then after and one year of study
motor developmental Change
Time frame: base line, after 6 months of study then after and one year of study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2023.
- Results publication: PubMed 25149833Rafique 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.
- Results publication: PubMed 25232151Ibrahim 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.
- Jafri SK, Kumar R, Ibrahim SH. Subacute sclerosing panencephalitis - current perspectives. Pediatric Health Med Ther. 2018;9:67-71Link provided by the sponsor.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shahnaz H Ibrahim, MBBS ;FCPS principal investigator
AKU
Questions about this trial
What is this clinical trial studying?
A study testing KETOGENIC DIET in people with SSPE, run by Aga Khan University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahnaz H Ibrahim, MBBS;FCPS (+923002119347, shahnaz.ibrahim@aku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seizure control (time frame: for a period of 6 months .). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152771, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2023.