Effect of Brain Stimulation on Stepping Performance in Stroke Survivors and Healthy Adults

NCT04437251 | Unknown

• 1 other identifier: IRB#17592- Phase I & II
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Participants are being asked to participate in a research study conducted by Shih-Chiao Tseng, PT, Ph.D. at Texas Woman's University. This research study is to determine whether low-intensive brain stimulation can enhance learning of a leg movement task. The investigators also want to know if brain stimulation can improve the nerve function and walking performance. Our goal is to understand any relationship between brain stimulation and overall movement control improvement. Participants have been invited to join this research if they have had a stroke before or they are healthy adults aged 21 years or older. Research evidence shows stroke can induce permanent brain damage and therefore may cause a person to have trouble learning a new task. This in turn may significantly impact the recovery of motor function in stroke survivors. In addition, the investigators also want to know how a healthy person learns this new leg task and see if her/his learning pattern differs from a stroke survivor. This study comprises two phases: Phase I study investigates short-term effects of brain stimulation on leg skill learning and only requires two visits to TWU. The total time commitment for Phase I study will be about 6.5 hours, 3.5 hours on the first visit and three hours on the second visit; Phase II study is an expanded version of Phase I study to investigate long-term effects of brain stimulation on leg skill learning and requires to complete 12 visits of exercise training paired with brain stimulation over a four-week period and additional one visit for follow-up test. The total time commitment for Phase II study will be about 20 hours, a total of 18 hours for 12 exercise training sessions and two hours for a follow-up test. The investigators hypothesize that people with chronic stroke will show a slower rate of acquiring this leg skill as compared to healthy adults. The investigators also hypothesize that co-applying brain stimulation with 12 sessions of exercise training will enhance skill learning of this leg task for people with chronic stroke and this 12-session exercise program may exert beneficial influences on the nerve function and leg muscle activation, and consequentially improve motor control for walking.

Conditions

Vascular Accident, Brain; CVA (Cerebrovascular Accident); Gait, Hemiplegic; Spastic Lower Extremity Weakness

Outcome Measures

Primary Outcomes (8)

• Changes in stepping reaction time (Phase I)

  Calculate the time duration for the central nervous system to process information and produce a stepping action.

  Measure changes in the reaction time before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation.

• Changes in stepping reaction time (Phase II)

  Calculate the time duration for the central nervous system to process information and produce a stepping action.

  Measure changes in reaction time before training, up to 24 hours after the completion of a 12-session training program, and one week after the completion of a 12-session training program.

• Changes in walking performance (Phase I)

  Measure walking speed (meters/second) during ground walking at a self-selected speed.

  Measure changes in the walking speed before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation.

• Changes in walking performance (Phase I)

  Measure step length (centimeters) symmetry (left/right) during ground walking at a self-selected speed.

  Measure changes in the step length symmetry before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation.

• Changes in walking performance (Phase II)

  Measure walking speed (meters/second) during ground walking at a self-selected speed.

  Measure changes in the walking speed before training, up to 24 hours after the completion of a 12-session training program, and one week after the completion of a 12-session training program.

• Changes in walking performance (Phase II)

  Measure step length symmetry (left/right) during ground walking at a self-selected speed.

  Measure changes in the step length symmetry before training, up to 24 hours after the completion of a 12-session training program, and one week after the completion of a 12-session training program.

• Changes in nerve function (Phase I)

  Place a surface electrode on the calf muscle to record muscle activation triggered by electrical stimulation delivered to the motor neurons in the lesioned motor cortex and tibial nerve on the paretic leg to qualify changes in neuronal activity in the primary cortex and in the spinal cord before and after brain stimulation (tDCS).

  Measure changes in the nerve function before, immediately after (i.e. within a minute), and 30 minutes after a single session of brain stimulation.

• Changes in nerve function (Phase II)

  Place a surface electrode on the calf muscle to record muscle activation triggered by electrical stimulation delivered to the motor neurons in the lesioned motor cortex and tibial nerve on the paretic leg to qualify changes in neuronal activity in the primary cortex and in the spinal cord before and after brain stimulation (tDCS).

  Measure changes in the nerve function before training, up to 24 hours after the completion of a 12-session training program), and one week after the completion of a 12-session training program.

Secondary Outcomes (4)

• Mini-mental State Examination (Phase I)

  Administer Mini-mental State Examination at the first visit before testing and training

• Mini-mental State Examination (Phase II)

  Administer Mini-mental State Examination at the first visit before testing and training

• Fugl-Meyer Lower Extremity Function Assessment (Phase I)

  Administer Fugl-Meyer Lower Extremity Function Assessment at the first visit before testing and training

• Fugl-Meyer Lower Extremity Function Assessment (Phase II)

  Administer Fugl-Meyer Lower Extremity Function Assessment at the first visit before testing and training

Study Arms (3)

Brain stimulation-induced improvements in leg skill learning

EXPERIMENTAL

To examine the degree of stimulation-induced improvements in learning capacity between three groups: stroke group, healthy young group, and healthy older group. Up to date, most studies have investigated the effects of brain stimulation on hand skill improvements in healthy young adults; little is known about stimulation-induced improvement in the "leg" skill improvement in stroke survivors as well as in older healthy adults. The investigators will answer the question: "Do stroke survivors improve leg skill learning at a comparable rate as healthy young and older adults after brain stimulation "transcranial direct current stimulation" (tDCS)?"

Device: Transcranial direct current stimulation (tDCS)

Effects of brain stimulation on functional improvements

EXPERIMENTAL

To determine the effect of brain stimulation (tDCS) on functional improvements in stroke survivors. Specifically, the investigators will compare stepping reaction time, cortical neuronal activity, peripheral nerve activity, and walking function in the stroke survivors before and after tDCS, and also compared these findings with results from healthy adults. The investigators will answer the question: "Do stroke survivors shorten stepping reaction time and improve leg muscle activation and gait performance after tDCS, and these improvements are at a similar rate as compared to data collected from healthy young and older adults?"

Device: Transcranial direct current stimulation (tDCS)

Effects of brain stimulation combined with stepping training

SHAM COMPARATOR

After enrolling to the study, participants with chronic stroke will be randomly assigned to one of two groups: anodal tDCS or sham tDCS groups. All subjects will then undergo a total of twelve training sessions over four weeks in which subjects will learn a novel visuomotor stepping task immediately after visuomotor learning training while 20-minute tDCS (anodal or sham stimulation) is delivered over the leg area of primary motor cortex.The investigators will measure changes in brain neuronal activity, peripheral nerve activity, and walking performance before and after a 12-session training program, and will follow up one week later.

Device: Transcranial direct current stimulation (tDCS)

Interventions

Transcranial direct current stimulation (tDCS) DEVICE

Transcranial direct current stimulation (tDCS) is an non-invasive, low-intensity direct current stimulation. The stimulation intensity is very low (0- 2 mA) to only produce tingling sensation on the scalp. From literature, there were no serious adverse effects reported after 20-minute stimulation. The main temporary side effect is skill irritation, itching sensation at the stimulation site during or after stimulation.

Brain stimulation-induced improvements in leg skill learning; Effects of brain stimulation combined with stepping training; Effects of brain stimulation on functional improvements

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy adults have no ongoing neurological, musculoskeletal issues.
• Individuals with chronic stroke had medical history of a unilateral stroke occurring ≥ 6 months prior to enrollment. MRI or CT evidence from the imaging report shown that the stroke involves the corticospinal tract.
• Individuals with chronic stroke have hemiparesis involving the lower extremity.
• Individuals with chronic stroke have no passive range of motion limitation in bilateral hips and knees. Limitation of ankle passive range of motion to 10 degrees of dorsiflexion or ess.
• Visual acuity can be corrected by glasses or contact lens to 20/20.
• Able to walk independently with/without assistant devices for 10 meters.
• Able to maintain standing position without any assistance for more than 30 sec.
• Evaluation of cognitive status: Mini-mental status examination (MMSE) score ≥ 24.

You may not qualify if:

• Pregnant women.
• MRI or CT evidence of involvement of the basal ganglia or cerebellum, evidence of multiple lesions, or evidence of any other brain damage or malignant neoplasm or tumors.
• Have any metal implants, cardiac pacemakers, or history of seizures.
• Ongoing orthopedic or other neuromuscular disorders that will restrict exercise training.
• Any vestibular dysfunction or unstable angina.
• Significant cognitive deficits (inability to follow a 2-step command) or severe receptive or global aphasia\*

Sponsors & Collaborators

• Texas Woman's University: lead

Study Sites (1)

Texas Woman's University

Houston, Texas, 77030, United States

RECRUITING

Related Publications (2)

• Matsumoto H, Ugawa Y. Adverse events of tDCS and tACS: A review. Clin Neurophysiol Pract. 2016 Dec 21;2:19-25. doi: 10.1016/j.cnp.2016.12.003. eCollection 2017.

  PMID: 30214966 BACKGROUND

• Tseng SC, Cherry D, Ko M, Fisher SR, Furtado M, Chang SH. The effects of combined transcranial brain stimulation and a 4-week visuomotor stepping training on voluntary step initiation in persons with chronic stroke-a pilot study. Front Neurol. 2024 Feb 21;15:1286856. doi: 10.3389/fneur.2024.1286856. eCollection 2024.

  PMID: 38450075 DERIVED

MeSH Terms

Conditions

Stroke; Gait Disorders, Neurologic; Paraparesis, Spastic

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paraparesis; Paresis

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Shih-Chiao Tseng, PT, PhD

  Texas Woman's University School of Physical Therapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shih-Chiao Tseng, PT, PhD

CONTACT

713-794-2309; stseng@twu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants will not be informed about their group assignments while learning a leg task. The testers who are conducting neurological and walking assessments before and after training will also be blinded from the group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: This study is a double-blinded, randomized controlled study in which participants will be randomly assigned into one of two brain stimulation groups (sham or real brain stimulation) while being evaluated for their ability of learning a leg task in a single session (phase I), and receiving a 12-session leg exercise training program.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 18, 2020
• Study Start: September 26, 2014
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: June 18, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)