Skip to main content

Table 1 Eligibility criteria

From: Pallidal neurostimulation versus botulinum toxin injections in the treatment of cervical dystonia: protocol of a randomized, sham-controlled trial (StimTox-CD)

Inclusion criteria Exclusion criteria
• Suffering from isolated, idiopathic or hereditary cervical dystonia for more than 2 years
• Moderate to severe symptom severity of dystonia (TWSTRS total score ≥ 20 points and TWSTRS motor score ≥ 15 points)
• Age between 18 and 75 years
• Adequate therapy response of BoNT A treatment during test injection procedure (≥ 25% reduction of points in TWSTRS motor score 4 weeks after baseline)
• Previous BoNT injection ≥12 weeks before screening visit
• Written informed consent to study participation, including patient’s agreement to undergo DBS procedure
▪ Mild dystonic symptoms (TWSTRS total score < 10 points and TWSTRS motor score < 5 points)
▪ Suffering from severe depression with ongoing suicidality (BDI > 25 points)
▪ Mild cognitive impairment (MCI) and dementia (MDRS ≤125 points)
▪ Ongoing acute psychosis
▪ Drug or alcohol abuse
▪ Pregnancy or lactation, women of childbearing age without secure contraception
▪ Illiteracy
▪ Surgical contraindication to DBS
▪ Concurrent participation in other clinical trials
▪ Any medical or psychological condition associated with the risk of insufficient compliance and/or early termination of the study