Clinical trial NCT05736653: PCMS Task After Moderate-to-severe Stroke
Official title: Strengthening Task Specific Activation of Paretic Hand Muscles After moderate-to- Severe Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Keywords: Stroke
Hand
Brain stimulation
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-02-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: We will employ a single group pre-post design.
Primary purpose: TREATMENT

Brief summary: Researchers at the University of Pittsburgh are conducting a research study to see how combining brain, nerve, and hand stimulation affect hand movement after stroke. The primary purpose of this study is to examine changes in the connection between the brain and the weak hand muscles after the combined brain, nerve, and hand stimulation. The primary hypothesis is that the combined brain, nerve, and hand stimulation will increase the the connection between the brain and the weak hand muscles. The secondary purpose of this study is to examine changes in weak hand's movement and function after the combined brain, nerve, and hand stimulation. The secondary hypothesis is that the combined brain, nerve, and hand stimulation will increase weak hand movement and function.

Detailed description: A total of 40 participants will be enrolled in this study. During the intervention sessions, Participants will receive three combinations of the brain, hand, and nerve stimulations.

Each participant will complete three intervention sessions for the short-term effect of the intervention. The time between sessions is 3-7 days. After data collection is completed for the short-term effect part of the study, 5 out of 40 participants will be randomly chosen to enroll in the long-term effect part of the intervention. Those participants will take part in 18 intervention sessions. The sessions will be administered three times a week for six weeks.

In the short-term effect part of the study, participants will complete the following three sessions:

1. Repeated brain, hand, and nerve stimulations while practicing a task. In this session, participants will receive 120 pairs of brain, hand, and nerve stimulation while repeatedly grasp and release a ball with the weak hand. The hand stimulation will help participants to release the ball.
2. Repeated brain and nerve stimulations during rest. In this session, participants will receive 120 pairs of brain and nerve stimulation while the weak hand is resting (or not performing a task).
3. Hand stimulation while practicing a task. In this session, participants will practice grasping and releasing the task 120 times with hand stimulation. The hand stimulation will help participants to release the ball.

In the long-term effect part of the study, participants will complete the following session (3/week for 6 weeks):

During the intervention, participants will receive repeated brain, hand, and nerve stimulations while practicing a task. They will receive 120 pairs of brain, hand, and nerve stimulation while repeatedly grasp and release a ball with the weak hand. The hand stimulation will help participants to release the ball. We will give rest breaks during the practice of the task.

Eligibility criteria: Inclusion Criteria:

1. Age between 18-85 years
2. Diagnosis of first-ever subcortical stroke (single cerebrovascular accident)
3. Stroke onset of at least six months prior to the time of participation
4. A score of at least 1 out of 2 on the spherical grasping item of the Fugl-Meyer Upper Extremity Subscale to allow participants to grasp the ball
5. Cognitive skills to actively participate, as indicated by scores of \> 23 on the Mini-Mental Status Examination
6. English speaking

Exclusion Criteria:

1. Inability to elicit a motor evoked potential (MEP) in the EDC muscle even with a 20% background muscle contraction
2. Presence of severe aphasia
3. Excessive spasticity of the wrist and finger muscles, defined as a Modified Ashworth Score \>2
4. Diagnosis of neurological disorders other than stroke
5. History of seizure or epilepsy
6. Orthopedic/musculoskeletal conditions (e.g., arthritis) affecting the upper extremity
7. Presence of metallic implants in the head or neck
8. Currently or planning to become pregnant
9. Difficulty maintaining alertness or remaining still
10. Ferromagnetic metallic implants, pacemakers, other implanted devices, or ventilators for magnetic resonance imaging (MRI)
11. Bodyweight \> 300 lbs due to MRI scanner dimensions (for subjects also undergoing MRI)
12. Psychiatric diagnosis according to the criteria of the Diagnostic and Statistical Manual of Mental Disorder, Fifth Edition (DSM-V), or who are on psychotropic medication
13. Life expectancy less than the duration of the study
14. Excessive pain in the paretic hand, defined as a Visual Analog Scale Score \>4
15. Participation in concurrent occupational therapy
16. Current use of recreational drugs and stimulants like cocaine and methylenedioxymethamphetamine (MDMA)

Primary outcomes:
measure: Transcranial magnetic stimulation to evaluate corticospinal transmission
timeFrame: Change from baseline up to 30-minutes post intervention
Secondary outcomes:
measure: Voluntary force production to evaluate motor performance
timeFrame: Change from baseline up to 30-minutes post intervention
measure: Maximum finger excursions to evaluate motor performance
timeFrame: Change from baseline up to 30-minutes post intervention
measure: Maximum finger spread to evaluate motor performance
timeFrame: Change from baseline up to 30-minutes post intervention
measure: Box and Block Test
timeFrame: Change from baseline up to 30-minutes post intervention
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: Neural Plasticity Rehabilitation and Movement Dynamics Lab
state: Utah
Study officials:
affiliation: University of Utah
name: Amit Sethi, PhD
role: PRINCIPAL_INVESTIGATOR
References: