Impact of rTMS on Abnormal Cortical fMRI in Patients With Dystonia
ConditionDystonia Disorder
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNorthwell Health
About this trial
By tracking resting-state fMRI scans, we aim to discover how repetitive transcranial magnetic stimulation (rTMS) changes brain connectivity in individuals with dystonia.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female
18 and 80 years of age.
Patients who manifest dystonia - sustained involuntary movement of the head, neck, trunk or limbs.
The dystonia may be spontaneous or genetic, specifically DYT1 or DYT6 and then only those patients who are demonstrating dystonia. The patient/subject will have a normal neurological exam except for dystonia.
Disqualifiers
Heredodegenrative dystonia of the type DYT8,9 or 10.
Past history of head trauma, stroke, epilepsy, demyelinating disease
Hypertension in excess of 160mmHg systolic and 90mmHg diastolic
Congestive heart failure
Trial design
Design model
Single group
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceContinuous theta-burst stimulation (cTBS), a modified form of rTMS that mimics natural brain rhythms (theta 4-8Hz), can effectively inhibit the cortical hyperactivity in targeted hubs with shorter treatment times than traditional approaches. The rationale for this proposed pilot experiment is to combine advanced analysis of standard neuroimaging to refine target location for a test of whether the application of non-invasive rTMS (in the form of cTBS) modulates abnormal cortical regions or the entire brain network, or both, as these networks underlie dystonia. This pilot study will provide the basis for a controlled study to test the effectiveness and robustness of any positive influence that TMS might have on the patients' dystonia.
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Active rTMS ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluating rs-fMRI Changes Following rTMS Treatment
The primary objective is to identify and modify replicable brain networks in dystonia patients using rs-fMRI. These networks reflect underlying disease processes, clinical symptomatology or both. The primary endpoint is change in the rs-fMRI derived network after rTMS treatment for two or four weeks, or both. We expect there to be changes at two and four weeks. We will then analyze the robustness of these changes in the repeat fMRI one week after treatment ends. Initially, identification and validation of the dystonia pattern from the resting state MRI will occur; it is a task with which we are familiar and is detailed in our recent manuscript.
Time frame
Two to four weeks.Sponsors and contacts
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Source ClinicalTrials.gov