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Bilateral Deep Brain Stimulation of the Globus Pallidus to Treat Tardive Dyskinesia
Philippe Damier, MD, PhD;
Stéphane Thobois, MD, PhD;
Tatiana Witjas, MD;
Emmanuel Cuny, MD;
Philippe Derost, MD;
Sylvie Raoul, MD, PhD;
Patrick Mertens, MD, PhD;
Jean-Claude Peragut, MD;
Jean-Jacques Lemaire, MD, PhD;
Pierre Burbaud, MD, PhD;
Jean-Michel Nguyen, MD, PhD;
Pierre-Michel Llorca, MD, PhD;
Olivier Rascol, MD, PhD; for the French Stimulation for Tardive Dyskinesia (STARDYS) Study Group
Arch Gen Psychiatry. 2007;64(2):170-176.
Context Tardive dyskinesia (TD) is a common and potentially disabling disorder induced by use of antipsychotic drugs for which medical treatment often gives disappointing results.
Objective To assess the efficacy of bilateral deep brain stimulation of the internal part of the globus pallidus to treat severe TD.
Design Prospective phase 2 multicenter study.
Setting Six French university hospitals.
Patients Patients with severe TD refractory to medical treatment were studied to evaluate the severity of abnormal involuntary movements before and after 6 months of bilateral globus pallidus deep brain stimulation. A 2-step open Fleming procedure was used to avoid unnecessary accrual of patients. A successful outcome was defined as a decrease of more than 40% in the main outcome measure at 6 months. The early stopping rule was invoked if the number of successful outcomes in 10 patients was fewer than 2, or 5 or more. A double-blind evaluation in the presence and absence of stimulation was performed at 6 months after surgery.
Main Outcome Measure Change in score on the Extrapyramidal Symptoms Rating Scale.
Results At 6 months after surgery, the Extrapyramidal Symptoms Rating Scale score had decreased compared with baseline by more than 40% (mean improvement, 61%; range, 44%-75%) in the first 10 patients included. In accord with the 2-step open Fleming procedure, we ended the trial at the first step and concluded that pallidal stimulation is an effective treatment for TD. The efficacy of the treatment was confirmed by a double-blind evaluation, with a mean decrease of 50% (range, 30%-66%) (P = .002) in the Extrapyramidal Symptoms Rating Scale score when stimulation was applied compared with the absence of stimulation. There were no marked changes in the patients' psychiatric status.
Conclusion Although these results need to be confirmed in a larger group of patients with a longer follow-up, bilateral globus pallidus deep brain stimulation seems to offer a much-needed new treatment option for disabling TD.
Author Affiliations: Centre Hospitalier Universitaire de Nantes, Centre d’Investigation Clinique (Drs Damier and Raoul) and Pôle d’Information Médicale, d’Evaluation, et de Santé Publique (Dr Nguyen), and Institut National de la Santé Publique et de la Recherche Médicale, Unité 643 (Dr Damier), Nantes; Hôpital neurologique Pierre Wertheimer, Lyon (Drs Thobois and Mertens); Assistance Publique de Marseille, Service de neurochirurgie fonctionnelle et stéréotaxique, Marseille (Drs Witjas and Peragut); Hôpitaux de Bordeaux, Services de neurophysiologie clinique et de neurochirurgie, Bordeaux (Drs Cuny and Burbaud); Centre Hospitalier Universitaire de Clermont-Ferrand, Services de neurologie A (Dr Derost), Neurochirurgie (Dr Lemaire), and Psychiatrie A (Dr Llorca), Clermont-Ferrand; and Centre Hospitalier Universitaire de Toulouse, Service de Pharmacologie, Centre d’Investigation Clinique, Pôle de Neurosciences, Toulouse (Dr Rascol); France.
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