Clinical neurotransplantation: Core assessment protocol rather than sham surgery as control
(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)
Please use this url to cite or link to this publication:
https://lup.lub.lu.se/record/325067
- author
- Boer, GJ and Widner, Håkan LU
- organization
- publishing date
- 2002
- 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
- additional info
- The information about affiliations in this record was updated in December 2015. The record was previously connected to the following departments: Neuronal Survival (013212041), Neurology, Lund (013027000)
- id
- 4c749e08-2b1b-468d-9f66-1e3f968d83fe (old id 325067)
- date added to LUP
- 2016-04-01 11:55:37
- date last changed
- 2022-01-26 20:16:11
@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}},
keywords = {{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}},
doi = {{10.1016/S0361-9230(02)00804-3}},
volume = {{58}},
year = {{2002}},
}