CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 32 enrolled
Drug / intervention
TMS +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03223623
NCT03223623N/ACompleted

Investigations of Pathophysiology of Focal Hand Dystonia

National Institute of Neurological Disorders and Stroke (NINDS)·interventional·Posted Jul 21, 2017·Updated Jul 1, 2022

In Brief

A clinical study evaluating TMS, MRI, and 1 other intervention for Dystonia. Completed, enrolled 32 participants across 1 site.

Detailed Summary

Background: Little is known about the problems in brain function in focal hand dystonia (FHD) or complex regional pain syndrome (CRPS) dystonia. It is unclear why some CRPS patients develop dystonia but others do not. Researchers want to learn which area of the brain is involved in CRPS dystonia compared with FHD. Objectives: To understand why people with CRPS develop dystonia, and if these reasons are different in people with FHD. Eligibility: Adults ages 18 - 70 with CRPS dystonia OR with CRPS without dystonia OR with FHD and Healthy volunteers of similar age. Design: Participants will be screened with physical exam, neurological exam, and medical history. They may give a urine sample and will answer questions. Participants can have 4 - 5 outpatient visits or stay at the clinical center for approximately 5-6 days. Participants will have MRI scans. They will lie on a table that slides in and out of a scanner that takes pictures of their brain. They will do small tasks or be asked to imagine things during the scanning. Participants will have transcranial magnetic stimulation (TMS) sessions for a few hours, with breaks. A brief electrical current passing through a well insulated wire coil on the scalp creates a magnetic pulse. This affects brain activity. Participants may do small tasks during TMS. Participants will have the electrical activity of their muscles measured during TMS sessions. Small sticky pads will be attached to their hands and arms. Participants ability to feel 2 separate stimuli as different will be tested by using a weak electrical shock to their fingers. They will also be asked to feel small plastic domes with ridges, that may cause discomfort.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDystonia
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartDec 12, 2017
Primary CompletionMay 18, 2022
TodayJul 1, 2026
Enrollment to primary: 4.4 yearsPosted 8.9 years ago

Interventions

TMSdevice

Single pulse TMS, IPL-M1 Interaction, IPL-M1 Interaction, Inhibitory Theta Burst Protocol (cTBS)

MRIdevice

High-resolution MRI for anatomical reference; fMRI scan as per research fMRI protocol will be conducted under 3 conditions. 1. Rest 2. Voluntary activity 3. Motor imagery task.

VASO Imagingdevice

The voluntary activity condition will involve 4 tasks: a. individual tapping of two fingers (index and little), b. individual tapping of four fingers (index, middle, ring, and little; no thumb) interspaced with rest periods, c. individual tapping of all five fingers (index, middle, ring, little, and thumb) interspaced with rest periods and d. Alternating grasping or retraction of a rubber ball interspaced with rest periods.