Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02106936
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
2014-04-03
Brief Title:
Depotentiation in People With Focal Hand Dystonia
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Depotentiation in Focal Hand Dystonia Patients
Status:
TERMINATED
Status Verified Date:
2017-06-20
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
- Focal hand dystonia FHD causes muscles to contract leading to abnormal movements or postures Musicians writers and athletes often get it Researchers want to study how patients with this condition learn a process of the brain that depends on a property called plasticity
Objective
- To study brain plasticity in people with FHD
Eligibility
Right-handed adults 18 years and older with FHD
Healthy right-handed adult volunteers
Design
Participants will be screened with medical history physical exam pregnancy test and questionnaire about their right-handedness
Participants will have 2 study visits on 2 different days
Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation TMS pulses on the left side of the head A brief electrical current passes through a wire coil on the scalp They will hear a click and may feel a pulling on the skin or muscle twitches They may have to keep their eyes open and remain alert tense certain muscles or perform simple finger movements
Forty more pulses with 10 seconds between will be given on the left side of the head Some will be small some big
Researchers will measure muscle response through small electrodes taped to the right hand
A cloth cap will be put on the participant s head Researchers will write on tape on the cap
Participants will have the r-PAS An electrical stimulator will be placed on the nerve at the right wrist Repeated magnetic pulses will be delivered in trains or short bursts together with electrical stimulation of nerve Participants will receive up to 840 pulses
Participants will be contacted after a few days for a follow-up check
- Focal hand dystonia FHD causes muscles to contract leading to abnormal movements or postures Musicians writers and athletes often get it Researchers want to study how patients with this condition learn a process of the brain that depends on a property called plasticity
Objective
- To study brain plasticity in people with FHD
Eligibility
Right-handed adults 18 years and older with FHD
Healthy right-handed adult volunteers
Design
Participants will be screened with medical history physical exam pregnancy test and questionnaire about their right-handedness
Participants will have 2 study visits on 2 different days
Participants will sit in a chair and have up to 30 Transcranial Magnetic Stimulation TMS pulses on the left side of the head A brief electrical current passes through a wire coil on the scalp They will hear a click and may feel a pulling on the skin or muscle twitches They may have to keep their eyes open and remain alert tense certain muscles or perform simple finger movements
Forty more pulses with 10 seconds between will be given on the left side of the head Some will be small some big
Researchers will measure muscle response through small electrodes taped to the right hand
A cloth cap will be put on the participant s head Researchers will write on tape on the cap
Participants will have the r-PAS An electrical stimulator will be placed on the nerve at the right wrist Repeated magnetic pulses will be delivered in trains or short bursts together with electrical stimulation of nerve Participants will receive up to 840 pulses
Participants will be contacted after a few days for a follow-up check
Detailed Description:
Objectives
Primary objectives
To explore the proper parameters creating a long-term depression LTD-like effect and depotentiation DePo by using rapid paired associative stimulation rPAS in focal hand dystonia FHD patients
Sample Size and Population
We plan to recruit 28 healthy volunteers HVs and 28 FHD patients from the Movement Disorders and Botulinum Toxin BoNT clinics of HMCS
Design
Phase 1 deals with HVs while phase 2 deals with FHD patients We will complete phase 1 before starting phase 2 Each phase is composed of 2 experiments In phase 1 experiments 1 and 2 will create the LTD-like effect and DePo in HVs and in phase 2 experiments 3 and 4 will elicit the LTD-like effect and DePo in FHD patients We will use regression analysis to show that the motor evoked potential MEP amplitude declines after eliciting the LTD-like effect and DePo
Outcome measurements
Primary outcome
Determining the parameters for creating the LTD-like effect and DePo in HVs and FHD using rPAS
Secondary outcome
Measuring the percent change of the MEP amplitude after applying the proper stimulus parameters causing an LTD-like effect and DePo in both HVs and FHD
Primary objectives
To explore the proper parameters creating a long-term depression LTD-like effect and depotentiation DePo by using rapid paired associative stimulation rPAS in focal hand dystonia FHD patients
Sample Size and Population
We plan to recruit 28 healthy volunteers HVs and 28 FHD patients from the Movement Disorders and Botulinum Toxin BoNT clinics of HMCS
Design
Phase 1 deals with HVs while phase 2 deals with FHD patients We will complete phase 1 before starting phase 2 Each phase is composed of 2 experiments In phase 1 experiments 1 and 2 will create the LTD-like effect and DePo in HVs and in phase 2 experiments 3 and 4 will elicit the LTD-like effect and DePo in FHD patients We will use regression analysis to show that the motor evoked potential MEP amplitude declines after eliciting the LTD-like effect and DePo
Outcome measurements
Primary outcome
Determining the parameters for creating the LTD-like effect and DePo in HVs and FHD using rPAS
Secondary outcome
Measuring the percent change of the MEP amplitude after applying the proper stimulus parameters causing an LTD-like effect and DePo in both HVs and FHD
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 |
|---|---|---|---|
| 14-N-0070 | None | None | None |