Patients with focal arm dystonia have increased sensitivity to slow-frequency repetitive TMS of the dorsal premotor cortex.
Hartwig R Siebner, Sasa R Filipovic, James B Rowe...
https://pubmed.ncbi.nlm.nih.gov/12937071/Actively Recruiting
Led by MGH Institute of Health Professions · Updated on 2026-02-20
25
Participants Needed
1
Research Sites
N/A
Total Duration
Laryngeal dystonia LD is a condition that causes excessive opening or closing of the vocal folds, leading to problems with voice quality, job prospects, self-worth, and overall quality of life. People with LD often experience symptoms like breathy voice, pitch breaks, and vocal tremor. While brain imaging has shown differences in brain areas related to voice control, the exact brain function behind LD is not fully understood. Current treatments like voice therapy and Botox injections provide temporary relief but have limitations. This research aims to study a non-invasive brain stimulation technique called repetitive transcranial magnetic stimulation rTMS to better understand and potentially improve brain control of voice muscles in LD. The study will compare 5 days of daily rTMS treatment targeting the left laryngeal motor cortex with a sham placebo rTMS treatment. Participants will receive about 20 minutes of rTMS each day using a specialized coil to stimulate brain areas responsible for voice muscle control. The sham treatment mimics the sensation and sound without actual brain stimulation. After the initial 5-day treatment and assessments, participants will cross over to receive the other treatment after at least 3 months. The study will measure voice changes and brain responses before and after each treatment phase. Participants will undergo detailed voice assessments, including listening tests, acoustic analysis, and self-reported voice effort ratings. Brain activity will be measured using a specialized neurophysiology assessment involving fine-wire electrodes inserted into voice muscles and brain stimulation tests to evaluate muscle control. Safety screenings will be done before treatments. Researchers will track changes in voice function and brain excitability at baseline, after treatment, and follow-up times. The total involvement includes initial screening, two treatment phases with assessments, and a follow-up period lasting several months.
CONDITIONS
Effects of Neuromodulation in Laryngeal Dystonia
C
Caitlin Koehler, Lab Manager
T
Teresa J Kimberley, PhD, PT
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MGH Institute of Health Professions
Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | Active repetitive transcranial magnetic stimulation (rTMS) | Sham repetitive transcranial magnetic stimulation (rTMS) |
|---|---|---|
| What it is | Active repetitive transcranial magnetic stimulation (rTMS) delivers targeted magnetic pulses to the laryngeal motor cortex for neuromodulation in adults with laryngeal dystonia. | Sham rTMS is applied to a non-relevant cortical area at subthreshold intensity, serving as a control to isolate the effects of active stimulation. |
| Role in the trial | Investigational neuromodulation approach aiming to modulate voice production and muscle activation. | Protocol-defined control condition enables blinded assessment of active rTMS effects. |
| Primary use | Test whether targeted neuromodulation improves phonatory function and alters cortical excitability in laryngeal dystonia. | Provide a blinded comparison to control for placebo and non-specific effects, as measured by phonatory and cortical outcomes. |
| How it is given or performed | rTMS is delivered using a magnetic coil placed over the laryngeal motor cortex at established stimulation intensity. | Sham stimulation uses placement over a cortical area not associated with laryngeal outcome at much lower intensity. |
| Evidence status | Ongoing clinical investigation with preliminary support for rTMS in focal dystonia and related motor disorders, but no published evidence in laryngeal dystonia. Safety profile and application guidelines established for clinical TMS use. | Protocol-defined control condition; there is no clinical efficacy or outcome evidence for sham stimulation in laryngeal dystonia. |
| Important limitations | The effect of rTMS on laryngeal dystonia is not yet established; prior evidence is limited to other focal dystonia types. Outcomes depend on accurate cortical targeting and participant tolerance of stimulation. Small trial size may limit broader applicability. | Sham condition does not represent an active clinical intervention for laryngeal dystonia, and cannot be compared with standard care options like botulinum toxin. |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
You may qualify if you...
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo baseline acoustic, perceptual, patient-reported voice assessments, and neurophysiologic testing including TMS measurement of cortical excitability and inhibition.
1 visit (in-person)
Duration - 5 days
Participants receive 5 consecutive days of real or sham repetitive transcranial magnetic stimulation (rTMS) targeting the left laryngeal motor cortex to assess effects on phonatory function.
Daily visits for 5 consecutive days
Duration - 1 day
After the 5-day rTMS intervention, participants undergo repeat acoustic, perceptual, patient-reported voice assessments, and neurophysiologic testing.
1 visit (in-person)
Duration - 7 days after post-treatment
Participants are assessed approximately one week after treatment for changes in phonatory function and self-ratings of voice effort.
1 visit (in-person)
Duration - Approximately 3 months later plus 7 days for assessments
At least 3 months after initial treatment, participants receive the alternate intervention (real or sham rTMS) following the same schedule of baseline assessment, 5-day treatment, post-treatment assessment, and follow-up.
Multiple visits including baseline, 5 daily treatment visits, post-treatment, and follow-up visits
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
Collaborating Sponsor