Propensity to Develop Plasticity in the Parieto- and Cerebello-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02504905|
Recruitment Status : Recruiting
First Posted : July 22, 2015
Last Update Posted : October 16, 2018
- People with dystonia have muscle contractions they can t control. These cause slow, repeated motions or abnormal postures. People with dystonia have abnormalities in certain parts of the brain. Researchers want to study the activity of two different brain areas in people with writer s cramp and cervical dystonia.
- To compare brain activity in people with dystonia to that in healthy people.
- Right-handed people ages of 18 60 with cervical dystonia or writer s cramp.
- Healthy volunteers the same ages.
- Participants will be screened with a physical exam. They will answer questions about being right- or left-handed.
- At study visit 1, participants will:<TAB>
- Have a neurological exam.
- Answer questions about how their disease impacts their daily activities.
- Have a structural magnetic resonance imaging (MRI) scan. Participants will lie on a table that can slide <TAB>in and out of a metal cylinder. This is surrounded by a strong magnetic field.
- Do 2 simple computer tasks.
- At study visit 2:
- Participants will have transcranial magnetic stimulations (TMS) at 2 places on the head. Two wire <TAB>coils will be held on the scalp. A brief electrical current creates a magnetic pulse that affects brain <TAB>activity. Muscles of the face, arm, or leg might twitch. Participants may have to tense certain muscles or do simple tasks during TMS. They may be asked to rate any discomfort caused by TMS.
- Muscle activity in the right hand will be recorded by electrodes stuck to the skin of that hand.
|Condition or disease|
|Writer's Cramp Healthly Volunteers Cervical Dystonia|
The purpose of this protocol is to improve understanding of the pathophysiology of dystonia by performing an electrophysiological study using plasticity induction protocols based on dual-site transcranial magnetic stimulation (TMS). We hypothesize that dystonic patients have enhanced responsiveness to plasticity induction in the parieto-motor network. In another exploratory study, we will also explore the responsiveness to plasticity induction of the cerebello-motor network. The clinical significance of such an enhanced plasticity will be evaluated by correlating the plasticity measurements with subjects' performance on two tasks engaging high-order motor processing and involving the parietal cortex and the cerebellum.
There will be one main study and one exploratory study with similar designs; the former will explore the parieto-motor network (PAR study) and the latter, the cerebello-motor network (CER study). There will be two independent arms in each study: one will compare patients with writer s cramp (WC) and age-matched healthy volunteers (HV); and the other one will compare patients with cervical dystonia (CD) with age-matched HVs. The power analysis of the main (PAR) study indicates that we need to enroll 17 patients and 17 healthy volunteers in each arm, with an additional 3 added to account for drop-outs. Therefore, we request a maximum of 20 subjects per patient group and 40 subjects for the control groups. A second power analysis for the exploratory CER study indicates that we need to enroll 13 healthy volunteers and 13 patients in each arm, with an additional 3 added to account for drop-outs. Thus, we request a maximum of 16 subjects per patient group and 32 subjects in the control groups.
Subjects will come for one screening visit and two outpatient study visits. During the first study visit patients will be scored clinically for dystonia and cerebellar signs. They will also undergo a structural magnetic resonance imaging (MRI) to locate the parietal target during the stimulation session. They will perform two motor learning tasks: a reaching task with visuomotor conflict and a predictive motor timing task. At least 24 hours later, during study visit two, subjects will receive TMS. TMS-induced electromyographic (EMG) activity of hand muscles will be recorded as motor evoked potentials (MEPs). Using single TMS shocks, we will measure at baseline, the input-output (I-O) curve for the right first dorsal interosseous (FDI) muscle MEPs. Then, the subjects will receive a plasticity induction protocol aiming to induce plasticity in the pathway linking the posterior parietal (PP) cortex and the primary motor cortex (M1). To that end, transcranial stimulation will be applied repeatedly (100 pairs) to the left angular gyrus in the PP cortex and to the left M1. At the end of the intervention, the I-O curve will be measured again over the next 50 minutes. The exploratory CER study will have the same experimental design. It differs from the PAR study only by the type of plasticity induction protocol used. Specifically, the cerebellum will be stimulated rather than the PP cortex.
The amplitude of the MEPs in the I-O curves gives information about corticospinal excitability as a function of TMS stimulation. The primary outcome measure will be MEP size with respect to time (before and 15-20 min after the plasticity intervention). The difference in MEP size will be compared between the HV and the patient groups using a T test. The performances on the behavioral tasks will be correlated with the primary outcome measure.
|Study Type :||Observational|
|Estimated Enrollment :||144 participants|
|Official Title:||Propensity to Develop Plasticity in the Parieto- & Cerebello-Motor Networks in Dystonia From the Perspective of Abnormal High-Order Motor Processing|
|Study Start Date :||July 21, 2015|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
- The primary outcome measure will be the percentage of change in MEP size between, before, and 15-20 min after PAS intervention (MEP post intervention/MEP pre intervention). The amplitude of the MEP in the EMG signal is the outcome measure giving... [ Time Frame: 15-20 min ]
- The duration of the post-effects will be assessed by the MEP size at the 4 time points. [ Time Frame: Pre & 5,15,25 ml ]
- Performance on the reaching task with a visuomotor conflict.Performance on the Predictive motor timing task. [ Time Frame: on going ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02504905
|Contact: Elaine P Considine, R.N.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|