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Repetitive transcranial magnetic stimulation in cervical dystonia: effect of site and repetition in a randomized pilot trial.

Pirio Richardson S, Tinaz S, Chen R - PLoS ONE (2015)

Bottom Line: ClinicalTrials.gov NCT01859247.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States of America.

ABSTRACT

Trial registration: ClinicalTrials.gov NCT01859247.

No MeSH data available.


Consort diagram.*Prior to enrolment, a randomization schedule was created by random sorting of the five rTMS sites for each subject. All 8 subjects each received rTMS to five separate sites including sham over the course of the trial. (See Table 2 for the randomized order of interventions by subjects).
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pone.0124937.g001: Consort diagram.*Prior to enrolment, a randomization schedule was created by random sorting of the five rTMS sites for each subject. All 8 subjects each received rTMS to five separate sites including sham over the course of the trial. (See Table 2 for the randomized order of interventions by subjects).

Mentions: The protocol for this trial and supporting CONSORT checklist are available as supporting information; see S1 CONSORT Checklist and S1 Protocol. We enrolled 9 CD patients (5 men) with mean age 53 years (standard deviation (SD) 16) (Table 1). As there was no prior data on the influence of rTMS on patients with CD using our primary outcome measure, we were not able to calculate a formal sample size and thus estimated that enrolling approximately 7 patients would be a reasonable approach for an exploratory trial. Patient recruitment began June 1, 2013 and patient follow-up was completed by July 31, 2014. Eight CD patients completed the study. One patient withdrew after enrolling, but prior to beginning any study intervention, due to an unexpected move out of state (Fig 1). The study intervention began at 8 weeks after their usual care botulinum toxin injection. All subjects met inclusion criteria: 1) patients with idiopathic cervical dystonia; 2) age 18 years or older; 3) normal findings in the medical history, physical and neurological examination, except for dystonia; and 4) last treatment with botulinum toxin more than two months prior to first intervention. All subjects did not have any exclusion criteria: 1) history of seizure disorder; 2) pregnancy- a pregnancy test will be performed for women of childbearing potential; 3) symptoms of a clinically relevant illness in the 4 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants with the exception of benzodiazepines; 4) history of neuroleptic medications/ prior use of neuroleptics; and 5) presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye. They all signed an informed consent. The study was approved by the University of New Mexico Health Sciences Center Institutional Review Board.


Repetitive transcranial magnetic stimulation in cervical dystonia: effect of site and repetition in a randomized pilot trial.

Pirio Richardson S, Tinaz S, Chen R - PLoS ONE (2015)

Consort diagram.*Prior to enrolment, a randomization schedule was created by random sorting of the five rTMS sites for each subject. All 8 subjects each received rTMS to five separate sites including sham over the course of the trial. (See Table 2 for the randomized order of interventions by subjects).
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4414555&req=5

pone.0124937.g001: Consort diagram.*Prior to enrolment, a randomization schedule was created by random sorting of the five rTMS sites for each subject. All 8 subjects each received rTMS to five separate sites including sham over the course of the trial. (See Table 2 for the randomized order of interventions by subjects).
Mentions: The protocol for this trial and supporting CONSORT checklist are available as supporting information; see S1 CONSORT Checklist and S1 Protocol. We enrolled 9 CD patients (5 men) with mean age 53 years (standard deviation (SD) 16) (Table 1). As there was no prior data on the influence of rTMS on patients with CD using our primary outcome measure, we were not able to calculate a formal sample size and thus estimated that enrolling approximately 7 patients would be a reasonable approach for an exploratory trial. Patient recruitment began June 1, 2013 and patient follow-up was completed by July 31, 2014. Eight CD patients completed the study. One patient withdrew after enrolling, but prior to beginning any study intervention, due to an unexpected move out of state (Fig 1). The study intervention began at 8 weeks after their usual care botulinum toxin injection. All subjects met inclusion criteria: 1) patients with idiopathic cervical dystonia; 2) age 18 years or older; 3) normal findings in the medical history, physical and neurological examination, except for dystonia; and 4) last treatment with botulinum toxin more than two months prior to first intervention. All subjects did not have any exclusion criteria: 1) history of seizure disorder; 2) pregnancy- a pregnancy test will be performed for women of childbearing potential; 3) symptoms of a clinically relevant illness in the 4 weeks before the first study day, including history of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants with the exception of benzodiazepines; 4) history of neuroleptic medications/ prior use of neuroleptics; and 5) presence of pacemaker, implanted medical pump, metal plate or metal object in skull or eye. They all signed an informed consent. The study was approved by the University of New Mexico Health Sciences Center Institutional Review Board.

Bottom Line: ClinicalTrials.gov NCT01859247.

View Article: PubMed Central - PubMed

Affiliation: Department of Neurology, University of New Mexico Health Sciences Center, Albuquerque, New Mexico, United States of America.

ABSTRACT

Trial registration: ClinicalTrials.gov NCT01859247.

No MeSH data available.