Ignite Creation Date:
2024-05-06 @ 1:43 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01888926
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2013-06-26
Brief Title:
The Effects of Repetitive Paired Associative Stimulation in Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Investigating the Plastic Effects of Repetitive Paired Associative Stimulation rPAS in Dystonia
Status:
COMPLETED
Status Verified Date:
2016-08-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Background
- People with dystonia have serious muscle contractions that cause abnormal movements or postures This significantly affects their daily lives The common type is called organic The other type is psychogenic People with this type have typical symptoms plus some psychological effects Researchers will look at how rapid transcranial magnetic stimulation rTMS of the brain combined with stimulation of a nerve affects the ability to detect sensations They will compare the responses of people with different types of dystonia They will also compare the responses of people with dystonia to responses of people without it This study may help us learn more about the nature of different types of dystonia
Objectives
- To see whether TMS combined with nerve stimulation affects the brain differently in people with different types of dystonia and those without dystonia
Eligibility
Individuals at least 18 years old who are right-handed and have dystonia
Healthy volunteers at least 18 years old
Design
Participants will have two clinical visits Each visit will be a few hours long They can be done on the same day
Participants will be screened with a medical history and physical exam
Participants will take several sensory tests For these tests electrodes will be placed on their skin The participants will feel small electric shocks during some of the tests
Participants will undergo TMS For 2 minutes quick electrical currents will pass through a wire coil placed on their head As this happens researchers will ask the participants to move certain muscles
- People with dystonia have serious muscle contractions that cause abnormal movements or postures This significantly affects their daily lives The common type is called organic The other type is psychogenic People with this type have typical symptoms plus some psychological effects Researchers will look at how rapid transcranial magnetic stimulation rTMS of the brain combined with stimulation of a nerve affects the ability to detect sensations They will compare the responses of people with different types of dystonia They will also compare the responses of people with dystonia to responses of people without it This study may help us learn more about the nature of different types of dystonia
Objectives
- To see whether TMS combined with nerve stimulation affects the brain differently in people with different types of dystonia and those without dystonia
Eligibility
Individuals at least 18 years old who are right-handed and have dystonia
Healthy volunteers at least 18 years old
Design
Participants will have two clinical visits Each visit will be a few hours long They can be done on the same day
Participants will be screened with a medical history and physical exam
Participants will take several sensory tests For these tests electrodes will be placed on their skin The participants will feel small electric shocks during some of the tests
Participants will undergo TMS For 2 minutes quick electrical currents will pass through a wire coil placed on their head As this happens researchers will ask the participants to move certain muscles
Detailed Description:
Objective
To investigate the effects of pairing brain and peripheral nerve stimulation in organic and psychogenic dystonia to see if this technique can differentiate them
Study Population
We intend to do an internal pilot study of 6 patients with organic dystonia 6 patients with clinically definite psychogenic dystonia and 6 age-matched healthy volunteers We will then perform an analysis to see how many subjects we need to prove or disprove a difference between groups
Design
Subjects will have a baseline screening visit electromyography EMG and nerve stimulation sensory threshold testing and measurements of brain excitability using motor evoked potentials MEPs from transcranial magnetic stimulation TMS They will then undergo rapid TMS repetitively paired with stimulation of a nerve in the arm Outcome variables will again be measured immediately after T0 30 minutes T30 after and 60 minutes T60 after the end of brain stimulation
Outcome Measures
Primary outcome variable Change in MEP amplitudes at T30 from baseline
Secondary outcome variables
Input-output curve parameters measured at baseline T0 T30 and T60
Temporal discrimination threshold TDT
Exploratory Measures
Short interval intracortical inhibition SICI a measure of inhibition in the motor cortex
Influence of Val66Met BDNF polymorphism on the output variables
Repeated measures analyses of variance ANOVA will be used to investigate the following three factors on the outcome variables time four levels baseline T0 T30 and T60 and muscle two levels APB and FDI as within-subject factor and group three levels organic dystonia psychogenic dystonia and healthy controls as between-subjects factor The model of repeated measures ANOVA will include the interactions between the three factors If the interaction between muscle and group is significant the interaction between time and group will be evaluated for each muscle separately If significance is found for time andor group then the evaluation will be followed by Tukey Kramer multiple pair-wise comparisons
To investigate the effects of pairing brain and peripheral nerve stimulation in organic and psychogenic dystonia to see if this technique can differentiate them
Study Population
We intend to do an internal pilot study of 6 patients with organic dystonia 6 patients with clinically definite psychogenic dystonia and 6 age-matched healthy volunteers We will then perform an analysis to see how many subjects we need to prove or disprove a difference between groups
Design
Subjects will have a baseline screening visit electromyography EMG and nerve stimulation sensory threshold testing and measurements of brain excitability using motor evoked potentials MEPs from transcranial magnetic stimulation TMS They will then undergo rapid TMS repetitively paired with stimulation of a nerve in the arm Outcome variables will again be measured immediately after T0 30 minutes T30 after and 60 minutes T60 after the end of brain stimulation
Outcome Measures
Primary outcome variable Change in MEP amplitudes at T30 from baseline
Secondary outcome variables
Input-output curve parameters measured at baseline T0 T30 and T60
Temporal discrimination threshold TDT
Exploratory Measures
Short interval intracortical inhibition SICI a measure of inhibition in the motor cortex
Influence of Val66Met BDNF polymorphism on the output variables
Repeated measures analyses of variance ANOVA will be used to investigate the following three factors on the outcome variables time four levels baseline T0 T30 and T60 and muscle two levels APB and FDI as within-subject factor and group three levels organic dystonia psychogenic dystonia and healthy controls as between-subjects factor The model of repeated measures ANOVA will include the interactions between the three factors If the interaction between muscle and group is significant the interaction between time and group will be evaluated for each muscle separately If significance is found for time andor group then the evaluation will be followed by Tukey Kramer multiple pair-wise comparisons
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 13-N-0163 | None | None | None |