ROLE OF PIRACETAM IN POST- CONCUSSION SYNDROME A PROSPECTIVE RANDOMIZED STUDY Deepak Agrawal, K Naveen*, CS Bal*, AK Mahapatra Departments of Neurosurgery*

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Presentation transcript:

ROLE OF PIRACETAM IN POST- CONCUSSION SYNDROME A PROSPECTIVE RANDOMIZED STUDY Deepak Agrawal, K Naveen*, CS Bal*, AK Mahapatra Departments of Neurosurgery* and Nuclear medicine*, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI, INDIA

AIIMS 2003 INTRODUCTION Post-concussion syndrome remains a poorly understood and treated condition Post-concussion syndrome remains a poorly understood and treated condition We describe a trial with ‘piracetam’, a drug We describe a trial with ‘piracetam’, a drug which has beneficial effects on the CBF by decreasing the adhesivity, aggregation, and deformability of erythrocytes along with flow thrust tension of the blood PIRACETAM IN MINOR HEAD INJURY

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY PREVIOUS STUDIES ON PIRACETAM IN MINOR HEAD INJURY WERE BASED ONLY ON ‘SUBJECTIVE CRITERIA’ FIRST STUDY OF ITS KIND BASED ON AN OBJECTIVE PARAMETER LIKE BRAIN SPECT

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY SENSTIVITY CT scan: 4.6%CT scan: 4.6% (Nedd K et al, 1993) MRI: 60%MRI: 60% ( (Kant R et al, 1997) SPECT: 81%SPECT: 81% (Present study)

AIIMS 2003 OBJECTIVE OBJECTIVE To correlate the symptomatic improvement with Single Photon Emission Computed Tomography (SPECT) findings, in patients with post-concussion syndrome (PCS), following administration of Piracetam (Cerecetam ® ) PIRACETAM IN MINOR HEAD INJURY

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY MATERIALS AND METHODS MATERIALS AND METHODS PROSPECTIVE STUDY PERIOD- JAN 2002 TO DEC 2002

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY 1. Loss of consciousness <30 minutes. 2. GCS score 13 to Posttraumatic amnesia <24 hours. MINOR HEAD INJURY [criteria published by the members of the Mild Traumatic brain injury Interdisciplinary Special Interest Group (BISIG)] Kay T, Harrington DE, et al. Definition of mild traumatic brain injury. J Head Trauma Rehabil 1993;8:86

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY Headache Headache Dizziness and vertigo Dizziness and vertigo Memory deficits Memory deficits Behavioral and emotional disturbances. Behavioral and emotional disturbances. POST CONCUSSION SYNDROME: (2 or more of the following) DSM IV criteria based on recommendation of Brown et al. Brown SJ, Fann JR, Grant I: Postconcussion disorder: time to acknowledge a common source of neurobehavioural morbidity. J Neuropsychiatry Clin Neurosci 6:15-22, 1994

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY MATERIALS AND METHODS (Contd.) NCCT head NCCT head INVESTIGATION SPECT scan brain SPECT scan brain Within 72 hours of injury

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY SPECT scanning was done using 99Tcm- ECD on a dual headed GE 'Varicam' scanner. The final data was displayed on a 10 grade color scale and semi quantitative analysis performed. The final data was displayed on a 10 grade color scale and semi quantitative analysis performed. SPECT

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY Regional cerebral perfusion <10% of contralateral lobe, or in case of bilateral involvement, less than 20% of cerebellum ABNORMAL SPECT SCAN

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY MATERIALS AND METHODS (Contd.)

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY Significant rise in the post treatment ratio in the piracetam group (mean: 0.959) as compared to the controls (mean: 0.013) (p= < % CI , ). RESULTS

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY RESULTS RESULTS P<0.05

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY RESULTS RESULTS

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY SPECT have been found to persist for as long as one year following minor head injury (Jocobs A, et al, 1996) Serial SPECT scanning can therefore provide an ideal platform to test the efficacy of various drugs in reversing these perfusion abnormalities in PCS.

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY Piracetam More than 12 g of piracetam has been given as daily dose in acute stroke (De Deyn PP et al, 1997) without significant side effects

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY CONCLUSIONS Cerebral perfusion defects occur in majority of the cases of postconcussion syndrome following minor head injury. Piracetam reverses cerebral perfusion deficits and may result in accelerated symptomatic improvement in patients with postconcussion syndrome.

AIIMS 2003 PIRACETAM IN MINOR HEAD INJURY THIS PRELIMINARY STUDY SHOWS THAT LOW DOSE PIRACETAM CAN BENEFIT PATIENTS WITH POSTCONCUSSION SYNDROME COST-EFFECTIVELY & WITHOUT APPRECIABLE SIDE EFFECTS. CONCLUSIONS (Contd.) A RANDOMISED CONTROLLED TRIAL IS PRESENTLY UNDERWAY FOR MORE DEFINITIVE RESULTS

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