Clinical trial NCT02542839: rTMS and Botulinum Toxin in Primary Cervical Dystonia
Official title: Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Cervical Dystonia
Dystonia
Keywords: Botulinum Toxin
Transcranial Magnetic Stimulation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: American Brain Foundation
name: Neuronetics
First posted: 2015-09-07
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently reported as a source of disability, decreased quality of life, and social stigma. Botulinum toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure symptomatic benefits and does not seem to modify the disease pathophysiology.

The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD. The primary goal of this study is to compare standard treatment with BoNT versus BoNT combined with a two week course of rTMS.

Detailed description: rTMS refers to the application of transcranial magnetic stimulation (TMS) pulses to a specific target at predefined stimulation parameters. Repeated sessions of rTMS therapy have been demonstrated to induce cumulative persistent benefits that can last weeks after the conclusion of the rTMS sessions

The central hypothesis of this study is that rTMS therapy in PCD can potentiate the effects of BoNT injections. With the current standard treatment, the peak-dose benefits seen with BoNT are seen at about 4-6 weeks after the administration of injections. The investigator will introduce a 1 week course of rTMS around 2-8 weeks before or after BoNT or T1). The investigator will examine the effects of combined therapy at 10 weeks after BoNT and 12 weeks after BoNT injections follow-up.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of PCD in accordance with the Consensus Statement of the Movement Disorder Society
* Subjects who report Botulinum Toxin benefits lasting 10 weeks or less only (suboptimal benefits with standard care)

Exclusion Criteria:

* Pregnancy
* Active seizure disorder
* Presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.

Primary outcomes:
measure: Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
timeFrame: absolute value at 12 weeks
Secondary outcomes:
measure: TMS Measure Referred to as Cerebellar Inhibition (CBI)
timeFrame: absolute value at 12 weeks
measure: Craniocervical Dystonia Questionnaire
timeFrame: absolute value at 12 Weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Center for Movement Disorders & Neurorestoration
state: Florida
city: Gainesville
country: United States
facility: UF Brain Institute
state: Florida
Study officials:
affiliation: UF Center for Movement Disorders and Neurorestoration
name: Aparna Wagle-Shukla, M.D.
role: PRINCIPAL_INVESTIGATOR
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citation: Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
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