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Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

University of New Mexico (UNM) logo

University of New Mexico (UNM)

Status

Completed

Conditions

Cervical Dystonia
Spasmodic Torticollis

Treatments

Device: rTMS

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01859247
U54NS065701 (U.S. NIH Grant/Contract)
UNM 657

Details and patient eligibility

About

The overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.

Full description

We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor areas in patients with cervical dystonia (CD) with the goal of improving symptoms and reducing unwanted side effects. The knowledge gained in this proposed research will identify a specific premotor area to be targeted with rTMS that is expected to result in a novel intervention that could enhance or replace current treatments for CD. rTMS could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. In addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rTMs has been FDA-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. Successful completion of this research could lead to rapid adoption of this therapeutic modality.

We will test the hypothesis that rTMS of a distinct premotor site will provide more effective treatment of CD than non-specific activation of the entire premotor region. This will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy for CD.

Enrollment

8 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Clinical diagnosis of idiopathic cervical dystonia
  • Age 18 years or older
  • Normal findings in the medical history, physical and neurological examination, except for dystonia
  • Last treatment with botulinum toxin more than two months ago

Exclusion criteria

  • History of seizure disorder
  • Pregnancy- a pregnancy test will be performed for women of childbearing potential
  • 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
  • History of neuroleptic medications/ prior use of neuroleptics

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

8 participants in 5 patient groups

Dorsal Premotor rTMS
Active Comparator group
Description:
0.2 Hz rTMS for 15 minutes
Treatment:
Device: rTMS
Primary motor cortex rTMS
Active Comparator group
Description:
0.2 Hz rTMS for 15 minutes
Treatment:
Device: rTMS
Supplemental Motor Area rTMS
Active Comparator group
Description:
0.2 Hz rTMS for 15 minutes
Treatment:
Device: rTMS
Anterior Cingulate rTMS
Active Comparator group
Description:
0.2 Hz rTMS for 15 minutes
Treatment:
Device: rTMS
Sham rTMS
Sham Comparator group
Description:
0.2 Hz rTMS for 15 minutes
Treatment:
Device: rTMS

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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