Long-term Outcome of DBS Versus Botulinum Toxin Treatment in Cervical Dystonia

NCT04432285 | Unknown

• 1 other identifier: 96307
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Cervical dystonia (CD) is the most common isolated dystonia in adults. Cervical dystonia symptoms can in most patients be managed well by botulinum toxin (BTX) injections, and supporting treatment measures. However, one-fifth to one-third of patients do not obtain sufficient relief from long-term BTX therapy, resulting in reduced quality of life. Deep brain stimulation (DBS) is a treatment method in which electrodes are surgically implanted permanently in the brain to modulate brain networks and function. In cervical dystonia, DBS of the postero-ventral part of the internal globus pallidus (GPi-DBS) has been established as an effective treatment for severe cases. However, the outcome of GPi-DBS in cervical dystonia has been reported mostly in some smaller series with up to 3 years follow-up. Thus, there is a lack of documentation of outcome of GPi-DBS in CD beyond 3 years of treatment and in larger patient materials. In this study the investigators will perform a long-term follow-up study of patients who were operated with a DBS-device targeting the GPi bilaterally, and who have been treated with chronic GPi-DBS for a minimum of 3 years. The investigators will measure the severity of symptom burden and quality of life with validated rating scales. The investigators will compare this DBS-treated cohort with an age- and gender matched group of CD patients who are receiving the standard treatment with botulinum neurotoxin (BoNT) injections and have been treated for at least 3 years as well. The investigators hypothesize that the DBS-treated group will have a significantly lower burden of symptoms at long-term follow-up than the BoNT treated group.

Conditions

Cervical Dystonia

Keywords

Deep Brain Stimulation; Botulinum Toxin treatment

Outcome Measures

Primary Outcomes (1)

• Total score of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS).

  The TWSTRS is a validated clinical scale that assesses cervical dystonia symptom severity, disability and pain (Consky et al, 1990; Consky and Lang 1994; Comella et al, 1992; Dubinsky et al, 1991). In the first part the physical signs of cervical dystonia are scored by the investigator (Severity subscale), the second part rates disability/limitation of activities (Disability subscale), and the third part rates the intensity and duration of pain related to the CD, and its impact on the patient´s ability to participate in normal activities (Pain subscale). The TWSTRS Total score is the sum of the TWSTRS Severity score (0-35), the TWSTRS Disability score (0-30) and the TWSTRS Pain score (0-20), with a maximum total score of 85. Higher scores indicate more severe symptoms/disability/pain.

  In the DBS-group: After 3-17 years of continuous GPi-DBS. In the BoNT-group: After minimum 3 years of regular BoNT injections (minimum 12 injection cycles), and 4-6 weeks after the last injection.

Secondary Outcomes (2)

• Severity, Disability and Pain subscores of the TWSTRS

  In the DBS-group: After 3-17 years of continuous GPi-DBS. In the BoNT-group: After minimum 3 years of regular BoNT injections (minimum 12 injection cycles),and 4-6 weeks after the last injection.

• Total score of the Cervical Dystonia Impact Profile 58 (CDIP-58)

  In the DBS-group: After 3-17 years of continuous GPi-DBS. In the BoNT-group: After minimum 3 years of regular BoNT injections (minimum 12 injection cycles), and 4-6 weeks after the last injection.

Study Arms (2)

Deep Brain Stimulation (GPi-DBS)

Patients with cervical dystonia (CD) who were operated at Oslo University Hospital between June 2004 and December 2017 with a DBS-device targeting the GPi bilaterally, and who have been treated with chronic GPi-DBS for a minimum of 3 years.

Device: DBS-device, implanted in GPi bilaterally

Botulinum toxin treatment

CD patients who for a minimum of 3 years have received treatment with botulinum neurotoxin (BoNT) injections at regular intervals (minimum 12 injection cycles) and still are receiving them (Age- and gender matched to the GPi-DBS group)

Drug: Botulinum toxin

Interventions

DBS-device, implanted in GPi bilaterally DEVICE

Chronic/continuous bilateral GPi-DBS

Deep Brain Stimulation (GPi-DBS)

Botulinum toxin DRUG

Repeated intramuscular injections at regular intervals of around 3 months

Botulinum toxin treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients who have cervical dystonia, focal or segmental, and who have been receiving either GPi-DBS, or Botulinum toxin injections, for a minimum of 3 years, and who still receives such treatment. All patients to be included give their written informed consent to participate.

You may qualify if:

• DBS-group: Patients with isolated cervical dystonia (focal or part of segmental dystonia) who have been operated at Oslo University between June 2004 and June 2017 and treated with bilateral GPi-DBS for a minimum of 3 years, and who give their informed consent to participate in this follow-up study.
• BoNT-group: Patients who are receiving regular BoNT-injections at Oslo University Hospital for isolated cervical dystonia (focal or part of segmental dystonia), who are gender-and age-matched to the operated patients, and who give their informed consent to participate in this follow-up study.

You may not qualify if:

• Dementia/inability to respond to the CDIP-58.

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, Norway

Location

Related Links

• Oslo University Hospital, homepage for Movement Disorders Research Group/Inger Marie Skogseid

MeSH Terms

Conditions

Torticollis

Interventions

Botulinum Toxins

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Inger Marie Skogseid, MDPhD

  Oslo University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant neurologist, Project leader

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 16, 2020
• Study Start: August 6, 2020
• Primary Completion: January 30, 2023
• Study Completion: December 31, 2024
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

NO (1)