Evaluate the role of reflexology as adjunctive therapy in the management of children with refractory Childhood Epilepsy including West Syndrome

Phase 2

Completed

• Conditions: Health Condition 1: null- Refractory Childhood Epilepsy and West syndrome

• Registration Number: CTRI/2010/091/002944
• Lead Sponsor: All India Institute of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

1. Age: 6 months to 12 years

2. Presence of seizures persisting daily or more than 7 per week despite the adequate trial of at least three tolerated and appropriately chosen and used anti-epileptic drugs including one newer antiepileptic drug (either alone or in combination). In case of infantile spasms, epileptic spasms with the onset before 2 years of age, with or without electroencephalographic evidence of hypsarrhythmia or its variants, persisting for more than 3 weeks, at least 7 cluster per week, despite treatment with at least 2 appropriate AEDs, and any one of the following; corticosteroids or vigabatrin.

3. Residents of Delhi/National capital region.

Exclusion Criteria

1.Known or suspected inborn error of metabolism, as evidenced by:

Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination

And/ or 2 or more of the following biochemical abnormalities

High blood ammonia ( >80mmol/L), High arterial lactate ( >2 mmol/L), metabolic acidosis (pH <7.2), hypoglycemia (blood sugar <40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.

2.Motivational or psychosocial issues in the family which would preclude compliance.

3.Systemic illness- chronic hepatic, renal or pulmonary disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified