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

Phase 2

Completed

Brief Summary: This study is a randomized controlled (open-label) trial. In this study, eligible children will be randomized to either receive adjunctive reflexology therapy along with the on-going standard therapy with anti-epileptic medications (intervention arm), or continue to receive the standard therapy with on-going antiepileptic medications (control arm). In both phases there will be a baseline period of 1 week. The baseline period will begin with a screening visit during which investigators obtain informed consent, assessed entry criteria, and performed screening procedures. These procedures included a complete physical and neurologic history and examination (pulse, blood pressure, and body weight) and laboratory testing (blood chemistry, hematology, urinalysis, and pregnancy test if appropriate). Patients or their parents or legal guardians maintained a diary in which they recorded spasm type and frequency. These diaries were reviewed, and the baseline seizure frequency will be calculated. Patients who complete the baseline period and still meet eligibility criteria enter into the treatment period. The treatment period was composed of a 4-week up-training period and an 8-week continuation period. This will be followed by a 1 week assessment period.

Recruitment & Eligibility

Inclusion Criteria

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.
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.

Primary Outcome Measures

Name	Time	Method
The primary outcome measure will be the efficacy of adjunctive reflexology in controlling seizures. This will be assessed by comparing seizure frequency at the end of the intervention period with the baseline seizure frequency the seizure frequency will be noted according to parental seizure charts.	3 months

Secondary Outcome Measures

Name	Time	Method
1.Change in the EEG characteristics and improvement in background of epileptiform abnormalities will be noted.	2.Change in the neural development status at the end of intervention period compared with baseline, in both groups DQ will be assessed far as possible.

Locations (1): Department of Biophysics, All India Institute of Medical Sciences, New Delhi
🇮🇳
Delhi, DELHI, India
Department of Biophysics, All India Institute of Medical Sciences, New Delhi
🇮🇳Delhi, DELHI, India
Dr D Elanchezhiyan
Principal investigator
011-26593215
chezhiyan123@gmail.com