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Vagus-Nerv-Stimulation (VNS):

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VNS THERAPY NEWS FLASH - ISSUE April 2004
VNS Therapy and Alzheimer's Disease (AD) and Migraines
Indication is not CE marked, currently under clinical investigation.
VNS Therapy may improve cognition in Alzheimer’s Disease (AD) patients
In this pilot study, ten patients with mild to moderate Alzheimer’s Disease (AD) were treated with VNS Therapy. All the included patients met the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer’s Disease and Related Disorders Association criteria for the diagnosis of Alzheimer’s disease.
Mean age of patients was 67 years and the mean duration of Alzheimer’s disease was 2.9 years. The mean Alzheimer’s Disease Assessment Scale - cognitive subscale (ADAS-cog) score at baseline was 21.9 and the mean Mini-Mental State Examination (MMSE) score was 21.
Response was defined as improvement in or no worsening of AD symptoms on the ADAS-cog and improvement or absence of impairment in MMSE scores.
Results:
After three months of VNS Therapy, seven of the ten patients with AD responded to VNS Therapy. Of the seven responders, six had improvements in their cognitive symptoms of AD and one had no worsening.
After six months of VNS Treatment, 7 patients were responders and the median improvement was 2.5 points.
After three months of VNS Therapy, nine of the ten patients were responders.
After six months of VNS Therapy, seven patients were responders and the median improvement 2.5 points.
No clear changes, whether decline or worsening, were found in affective, behavioural, or quality-of-life measures. However, several spouses reported improvements in these aspects.
VNS Therapy was safe and well tolerated, and all patients chose to continue with VNS Therapy after the scheduled 6 months.
The results of this open-label pilot study suggest a positive effect of VNS Therapy on cognition in patients with Alzheimer’s disease. Further studies are warranted.
Source : Magnus J.C. Sjögren et al., J Clin Psychiatry 2002; 63: 972‐980.
The effect of VNS Therapy on Migraines
VNS Therapy inhibits nociceptive behaviour in animals. For this study, all patients who received VNS Therapy for pharmacoresistant epilepsy between 1993 and 1999 at Southern Illinois University were contacted. Patients who had concomitant chronic pain were subsequently interviewed. Pain intensity before and after VNS Therapy was rated by the patient as average, worse, and least and on numeric rating scale from 1 to 10. Four patients of the 27 interviewed had common migraine and no other chronic pain syndromes were identified. All patients with migraine reported reductions in headache frequency and numeric rating scale score for average and least headache intensity. One patient reported complete relief of headaches on Global Pain Relief Rating Scale.

Intensity and Frequency of Headaches Before and After VNS Therapy Implantation
	Average Pain		Worst Pain		Least Pain		Frequency Headaches
	Before VNS	After VNS	Before VNS	After VNS	Before VNS	After VNS	Before VNS	After VNS
Patient 1	4	0	7	0	0	0	0.625/wk	0
Patient 2	6.5	5	10	10	3	0	2.5/wk	1.5/wk

Patient 3	6.5	3.5	10	6.5	0	0	0.625/wk	0.1/wk

Patient 4	5.5	2	10	5.5	1.5	0	1.5/wk	0.25/wk

Average	5.625	2.625	9.25	5.5	1.125	0	1.31/wk	0.46/wk

Standard deviation	1.18	2.14	1.5	4.14	1.44	0	0.839/wk	0.699/wk

Abbreviation: VNS, vagus nerve stimulation
The results observed suggest that chronic VNS Therapy could reduce the frequency and severity of migraine headaches. The effect of VNS Therapy on migraine was not immediate and was observed between one to three months after initiation of VNS Therapy. Therefore chronic VNS Therapy might be beneficial for prophylactic therapy of migraine. Large prospective studies to support this observation are needed.
Source : E. Daniela Hord et al.,The Journal of Pain 2003;4 (No 9):530- 534.
Please refer to the attached brief summary for prescribing and safety information
EUROPEAN INTENDED USE / INDICATION FOR DEPRESSION
The VNS Therapy System is indicated for treatment of chronic or recurrent depression in patients that are in treatment-resistant or treatment-intolerant major depressive episode.
EUROPEAN INTENDED USE/ INDICATION FOR EPILEPSY
The VNS Therapy System is indicated for use as an adjunctive therapy in reducing the frequency of seizures in patients whose epileptic disorder is dominated by partial seizures (with or without secondary generalisation) or generalised seizures, which are refractory to antiepileptic medications.

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