Improving Hand Movement Training Through Electrical Stimulation of the Brain
|ClinicalTrials.gov Identifier: NCT00331318|
Recruitment Status : Completed
First Posted : May 29, 2006
Last Update Posted : July 2, 2017
|First Submitted Date||May 27, 2006|
|First Posted Date||May 29, 2006|
|Last Update Posted Date||July 2, 2017|
|Study Start Date||May 24, 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT00331318 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Improving Hand Movement Training Through Electrical Stimulation of the Brain|
|Official Title||Encoding a Motor Memory Through Metaplasticity|
This study will determine if applying electrical stimulation of the brain can influence training to perform finger movements. The study may provide information that can be used to design rehabilitation therapies for people who have lost the ability to move a part of their body, such as an arm, leg, or hand following a stroke.
Healthy volunteers 18-50 years of age may be eligible for this study. Candidates are screened with a medical history, physical examination, MRI (if one has not been done within the last year), questionnaire to evaluate memory and attention and a pregnancy test for women who can become pregnant.
Participants have the following tests and procedures in seven sessions over about 8 weeks:
Training leads to performance improvements and motor learning. Cortical plasticity associated with training (use-dependent plasticity, UDP) contributes to performance improvements after brain lesions such as stroke. Recently, several interventional strategies have been proposed to enhance UDP, including pharmacological approaches and brain stimulation. The magnitude of improvements identified with these techniques is limited. It would be very useful to enhance UDP beyond the limited effects of previously proposed interventions.
One strategy recently proposed to enhance the effect of brain stimulation techniques on the cerebral cortex is metaplasticity. This strategy focuses on the purposeful manipulation of cortical activity before applying brain stimulation. For example, previous work demonstrated that the magnitude of increase in cortical excitability elicited by stimulation of the primary motor cortex (M1) is more prominent if stimulation is applied on a hypoactive M1. An initial down-regulation of M1 activity (i) amplifies the effect of a subsequent intervention that increases M1 activity, and (ii) reduces inter-individual variability.
It is unknown if this metaplasticity strategy can enhance the beneficial effects of anodal tDCS (tDCS anodal) on training effects as it does with cortical excitability, an issue of scientific and clinical interest, and the overall hypothesis of this protocol.
Here, we will test the hypothesis that metaplasticity (tDCS cathodal) followed by tDCS anodal plus motor training will result in more prominent UDP than control interventions.
6 healthy adult volunteers for parameters estimation plus 25 healthy adult volunteers (total = 31 healthy adult volunteers)
In this protocol, down-regulation of M1 activity will be accomplished by applying tDCS cathodal, a tool extensively described in the literature to induce this effect. Therefore, we will test the effects of this metaplasticity intervention on the beneficial action of tDCS anodal to M1 in combination with motor training (MT). After a familiarization session, subjects will participate in 6 randomized sessions in a cross-over design:
MT will consist of brisk repetitive thumb movements in a direction opposite to the baseline direction of thumb movements evoked by focal transcranial magnetic stimulation (TMS), in a well-characterized UDP protocol.
The primary outcome measure reflecting the encoding of a motor memory will be the increased proportion of TMS-evoked movements falling within the target training zone (TTZ) as a function of MT and metaplasticity interventions.
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
|Publications *||Siebner HR, Lang N, Rizzo V, Nitsche MA, Paulus W, Lemon RN, Rothwell JC. Preconditioning of low-frequency repetitive transcranial magnetic stimulation with transcranial direct current stimulation: evidence for homeostatic plasticity in the human motor cortex. J Neurosci. 2004 Mar 31;24(13):3379-85.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Same as current|
|Study Completion Date||April 21, 2008|
|Primary Completion Date||Not Provided|
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||Yes|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||060171
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||April 21, 2008|