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Clinical neurotransplantation: Core assessment protocol rather than sham surgery as control

Boer, GJ and Widner, Håkan LU (2002) In Brain Research Bulletin 58(6). p.547-553
Abstract
Basic neurotransplantation research evoked clinical trials of restorative brain surgery. Parkinson's disease was the first and primary test bed for this putative new therapeutic method. Various centers performed the grafting surgery and the behavioral evaluations in different ways, and observed a varying degree of symptomatic relief. This led to a plea for double blind placebo-controlled clinical trials, which have since been performed and of which the first outcomes were recently published. In the present paper this approach of experimental neurotransplantation in brain diseases is discussed and rejected. Neural grafting in the central nervous system is irreversible and is therefore not suitable for experimental approaches originally... (More)
Basic neurotransplantation research evoked clinical trials of restorative brain surgery. Parkinson's disease was the first and primary test bed for this putative new therapeutic method. Various centers performed the grafting surgery and the behavioral evaluations in different ways, and observed a varying degree of symptomatic relief. This led to a plea for double blind placebo-controlled clinical trials, which have since been performed and of which the first outcomes were recently published. In the present paper this approach of experimental neurotransplantation in brain diseases is discussed and rejected. Neural grafting in the central nervous system is irreversible and is therefore not suitable for experimental approaches originally designed for and best suited to drug studies. For Parkinson's disease in particular, the technique is far from optimized to perform large-scale studies at this stage. Moreover, previous negative results of adrenal medulla tissue implantation in the brain of patients make placebo effects rather unlikely. Moral arguments concerning the validity of the informed consent, therapeutic misconception, and the risk/benefit ratio can be added in the plea against this control surgery. Finally, a recommendation is made for study designs that apply a disease-dedicated core assessment protocol (CAP) that can evaluate the period from pre-operative to post-convalescent stages quantitatively, and therefore, unbiased. The strength of these CAPs is that they allow comparisons of different grafting techniques, of results between centers and of other types of interventions and invasive treatments such as deep brain stimulation. On ethical grounds, it is unacceptable not to use a study design that circumvents sham or imitation surgery. It is a challenge for the neuroscience community to develop CAPs for brain diseases that are eligible for neurotransplantation in the future. (C) 2002 Elsevier Science Inc. All rights reserved. (Less)
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author
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
core assessment protocol, ethics, sham surgery, double blind, neurotransplantation, Parkinson's disease
in
Brain Research Bulletin
volume
58
issue
6
pages
547 - 553
publisher
Elsevier
external identifiers
  • wos:000178779200005
  • pmid:12372557
  • scopus:0037201104
ISSN
0361-9230
DOI
10.1016/S0361-9230(02)00804-3
language
English
LU publication?
yes
id
4c749e08-2b1b-468d-9f66-1e3f968d83fe (old id 325067)
date added to LUP
2007-08-10 11:54:09
date last changed
2017-05-14 03:30:48
@article{4c749e08-2b1b-468d-9f66-1e3f968d83fe,
  abstract     = {Basic neurotransplantation research evoked clinical trials of restorative brain surgery. Parkinson's disease was the first and primary test bed for this putative new therapeutic method. Various centers performed the grafting surgery and the behavioral evaluations in different ways, and observed a varying degree of symptomatic relief. This led to a plea for double blind placebo-controlled clinical trials, which have since been performed and of which the first outcomes were recently published. In the present paper this approach of experimental neurotransplantation in brain diseases is discussed and rejected. Neural grafting in the central nervous system is irreversible and is therefore not suitable for experimental approaches originally designed for and best suited to drug studies. For Parkinson's disease in particular, the technique is far from optimized to perform large-scale studies at this stage. Moreover, previous negative results of adrenal medulla tissue implantation in the brain of patients make placebo effects rather unlikely. Moral arguments concerning the validity of the informed consent, therapeutic misconception, and the risk/benefit ratio can be added in the plea against this control surgery. Finally, a recommendation is made for study designs that apply a disease-dedicated core assessment protocol (CAP) that can evaluate the period from pre-operative to post-convalescent stages quantitatively, and therefore, unbiased. The strength of these CAPs is that they allow comparisons of different grafting techniques, of results between centers and of other types of interventions and invasive treatments such as deep brain stimulation. On ethical grounds, it is unacceptable not to use a study design that circumvents sham or imitation surgery. It is a challenge for the neuroscience community to develop CAPs for brain diseases that are eligible for neurotransplantation in the future. (C) 2002 Elsevier Science Inc. All rights reserved.},
  author       = {Boer, GJ and Widner, Håkan},
  issn         = {0361-9230},
  keyword      = {core assessment protocol,ethics,sham surgery,double blind,neurotransplantation,Parkinson's disease},
  language     = {eng},
  number       = {6},
  pages        = {547--553},
  publisher    = {Elsevier},
  series       = {Brain Research Bulletin},
  title        = {Clinical neurotransplantation: Core assessment protocol rather than sham surgery as control},
  url          = {http://dx.doi.org/10.1016/S0361-9230(02)00804-3},
  volume       = {58},
  year         = {2002},
}