Clinical trial NCT02098265: A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Official title: A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: aneurysm
transient ischemic attack
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: American Heart Association
First posted: 2014-03-27
Enrollment: 288
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke recovery.

Detailed description: The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery on behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).

Adult stroke patients with upper extremity motor impairments (henceforth "experimental group"), healthy controls, and participants with risk factors for stroke, without upper extremity impairment (allowing them to serve as controls for patients with upper extremity impairments (henceforth "control group")), will be recruited in this study. Half of the participants in the experimental group will be randomly assigned to the EEG-BCI (brain-computer interface) training ("closed-loop") group and will receive training on the BCI task along with muscle and tongue stimulation. The other half of the participants in the experimental group receiving traditional rehab will not receive any kind of FES or tongue stimulation for the first 8-10 weeks of study period and then will start receiving BCI-FES-tongue stimulation rehab therapy.

All participants without UE impairment in Control group 1 will receive 4-6 (minimum 4, up to a maximum of 6) sessions of training on the BCI system and pre- and post MRI and 2 behavioral testing sessions.

Addition of a Control group 2 is consistent with the AHA grants - Twenty four ischemic stroke patients with moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45); no upper extremity injury or conditions that limited use prior to the stroke; and pre-stroke independence with a Modified Rankin Score of 0 or 1), will be recruited in this arm. All participants in this group will receive MR sessions and behavioral testing similar to the Experimental group.

Addition of an Experimental group receiving EEG-BCI-bilateral FES intervention using the recoveriX system: recoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions. Through the EEG-based recoveriX BCI system, the brain receives visual and tactile feedback in real-time, making rehabilitation more effective. A stroke patient imagines a hand movement while receiving visual feedback through a virtual avatar, and tactile feedback through electrical muscle stimulation paired to the patient's imagined movement, with the aim that these patients might regain the volitional ability to grasp following therapy. Unlike the current EEG-BCI-FES intervention that involves stimulation of only the impaired arm, with recoveriX, both arms are simultaneously stimulated during the course of the intervention.

Specific Aims

To determine if functional muscle stimulation of the arms, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increase the extent of stroke recovery as measured by behavioral measures and induce brain plasticity as measured by functional magnetic resonance imaging (fMRI).

Primary objective

* To examine the effect of EEG guided functional muscle stimulation on improvement in upper extremity function

Secondary objective

* To examine plasticity changes as measured by EEG/fMRI measures before and after EEG guided functional muscle stimulation.

Eligibility criteria: Inclusion Criteria (Experimental Group):

* Stroke patients with persistent upper extremity (UE) deficits

Inclusion Criteria (Control Group 1)

* Stroke patients without UE impairments
* Participants with risk factors for stroke
* healthy controls

  * No known neurologic, psychiatric or developmental disability

Inclusion Criteria (Control Group 2)

* Stroke patients with persistent upper extremity (UE) deficits
* Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)
* No upper extremity injury or conditions that limited use prior to the stroke
* Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Exclusion Criteria (for all participants):

* Allergic to electrode gel, surgical tape and metals
* Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
* Women who are pregnant or may become pregnant during the course of the study will be excluded
* Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)

Exclusion Criteria (for healthy controls)

* Contraindications for MRI
* Allergic to electrode gel, surgical tape, and metals.

Primary outcomes:
measure: Action Research Arm Test Scores
timeFrame: 4 months
Secondary outcomes:
measure: Change in Electroencephalogram (EEG) Response Strength
timeFrame: 4 months
measure: Signal change in functional MRI
timeFrame: 4 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Vivek Prabhakaran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Young BM, Stamm JM, Song J, Remsik AB, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Brain-Computer Interface Training after Stroke Affects Patterns of Brain-Behavior Relationships in Corticospinal Motor Fibers. Front Hum Neurosci. 2016 Sep 16;10:457. doi: 10.3389/fnhum.2016.00457. eCollection 2016.
citation: Young BM, Nigogosyan Z, Walton LM, Remsik A, Song J, Nair VA, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Dose-response relationships using brain-computer interface technology impact stroke rehabilitation. Front Hum Neurosci. 2015 Jun 23;9:361. doi: 10.3389/fnhum.2015.00361. eCollection 2015.
citation: Song J, Nair VA, Young BM, Walton LM, Nigogosyan Z, Remsik A, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. DTI measures track and predict motor function outcomes in stroke rehabilitation utilizing BCI technology. Front Hum Neurosci. 2015 Apr 27;9:195. doi: 10.3389/fnhum.2015.00195. eCollection 2015.
citation: Song J, Young BM, Nigogosyan Z, Walton LM, Nair VA, Grogan SW, Tyler ME, Farrar-Edwards D, Caldera KE, Sattin JA, Williams JC, Prabhakaran V. Characterizing relationships of DTI, fMRI, and motor recovery in stroke rehabilitation utilizing brain-computer interface technology. Front Neuroeng. 2014 Jul 29;7:31. doi: 10.3389/fneng.2014.00031. eCollection 2014.
citation: Young BM, Nigogosyan Z, Nair VA, Walton LM, Song J, Tyler ME, Edwards DF, Caldera K, Sattin JA, Williams JC, Prabhakaran V. Case report: post-stroke interventional BCI rehabilitation in an individual with preexisting sensorineural disability. Front Neuroeng. 2014 Jun 24;7:18. doi: 10.3389/fneng.2014.00018. eCollection 2014.
citation: Remsik AB, Williams L Jr, Gjini K, Dodd K, Thoma J, Jacobson T, Walczak M, McMillan M, Rajan S, Young BM, Nigogosyan Z, Advani H, Mohanty R, Tellapragada N, Allen J, Mazrooyisebdani M, Walton LM, van Kan PLE, Kang TJ, Sattin JA, Nair VA, Edwards DF, Williams JC, Prabhakaran V. Ipsilesional Mu Rhythm Desynchronization and Changes in Motor Behavior Following Post Stroke BCI Intervention for Motor Rehabilitation. Front Neurosci. 2019 Mar 6;13:53. doi: 10.3389/fnins.2019.00053. eCollection 2019.
citation: Remsik AB, Dodd K, Williams L Jr, Thoma J, Jacobson T, Allen JD, Advani H, Mohanty R, McMillan M, Rajan S, Walczak M, Young BM, Nigogosyan Z, Rivera CA, Mazrooyisebdani M, Tellapragada N, Walton LM, Gjini K, van Kan PLE, Kang TJ, Sattin JA, Nair VA, Edwards DF, Williams JC, Prabhakaran V. Behavioral Outcomes Following Brain-Computer Interface Intervention for Upper Extremity Rehabilitation in Stroke: A Randomized Controlled Trial. Front Neurosci. 2018 Nov 8;12:752. doi: 10.3389/fnins.2018.00752. eCollection 2018.