tACS for Sensory Motor Recovery After Stroke

• ClinicalTrials.gov Identifier: NCT06029062
• Recruitment Status: Not yet recruiting
• First Posted: September 8, 2023
• Last Update Posted: May 8, 2024
• Sponsor: The University of Texas Health Science Center, Houston
• Information provided by (Responsible Party): Sheng Li, The University of Texas Health Science Center, Houston

Tracking Information

• First Submitted Date: May 10, 2023
• First Posted Date: September 8, 2023
• Last Update Posted Date: May 8, 2024
• Estimated Study Start Date: September 1, 2024
• Estimated Primary Completion Date: September 30, 2027 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 31, 2023)

• Block and Box Test (BBT) of Motor functional test [ Time Frame: Change of BBT performance 5 minutes before and 5 minutes after the tACS intervention will be measured. ]
  The Box and Block Test (BBT) measures unilateral gross manual dexterity. It is a quick and simple test used with a wide range of populations, including clients with stroke.
• EEG alpha band and Beta band [ Time Frame: Change of EEG alpha band and Beta band 5 minutes before and 5 minutes after the tACS intervention will be measured. ]
  Electroencephalography (EEG) is valuable to infer and evaluate the neural interaction. Components of the alpha and beta frequency bands like the sensorimotor rhythm originated from the primary motor cortex and related brain areas reflect human movement. The power of 8-13 Hz alpha and 14-30 Hz beta frequency bands will be used for the classification.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: tACS for Sensory Motor Recovery After Stroke
• Official Title: tACS Brain Neuromodulation for Sensory and Motor Recovery After Neurological Impairments
• Brief Summary: The overall goal is to investigate the effectiveness of a novel intervention - transcranial alternating current stimulation (tACS) for motor recovery in stroke survivors.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Motor Recovery

Intervention

• Device: tACS Sham
  Sham tACS will applied to the brain through the scalp for 20 minutes.
• Device: tACS 10Hz
  10Hz tACS will applied to the brain through the scalp for 20 minutes.
• Device: tACS 20Hz
  20Hz tACS will applied to the brain through the scalp for 20 minutes.

Study Arms

• Experimental: tACS Sham, tACS 10Hz, tACS 20Hz

  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.

  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

  Interventions:

  • Device: tACS Sham
  • Device: tACS 10Hz
  • Device: tACS 20Hz
• Experimental: HD-tACS 20Hz, HD-tACS 10Hz, HD-tACS Sham

  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.

  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

  Interventions:

  • Device: tACS Sham
  • Device: tACS 10Hz
  • Device: tACS 20Hz
• Experimental: HD-tACS 10Hz, HD-tACS 20Hz, HD-tACS Sham

  tACS Sham is a temporary non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for up to 30 second, it is not designed to entrain neuronal activity into any external regulatory frequency patterns.

  tACS 10Hz is a 10Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp or 20 or 40 minutes to entrain neuronal activity into 10Hz frequency patterns.

  tACS 20Hz is a 20Hz non-invasive electrical stimulation that applies a weak oscillatory current to the brain through the scalp for 20 or 40 minutes to entrain neuronal activity into 20Hz frequency patterns.

  Interventions:

  • Device: tACS Sham
  • Device: tACS 10Hz
  • Device: tACS 20Hz

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Not yet recruiting
• Estimated Enrollment (submitted: August 31, 2023): 14
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: March 31, 2028
• Estimated Primary Completion Date: September 30, 2027 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion/exclusion criteria for stroke subjects

Inclusion criteria:

1. Age between 18~75 years old
2. ≥ 6 months post stroke, medically stable;
3. Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
4. Visible finger flexor activation/movement
5. The ability to give consent

Exclusion criteria:

1. Patients with visual deficit/neglect; hearing or cognitive impairment;
2. Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
3. Patients received botulinum toxin injection to the arm/fingers <4 months, or phenol injections <2 years;
4. Patients with pacemaker, metal implants or supplemental oxygen;
5. Patients who have musculoskeletal disorders, including pain in the affected side
6. Women who are pregnant.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Sheng Li, MD, Ph.D; (713) 797-7125; sheng.li@uth.tmc.edu

Contact: Shengai Li, MS; 713-797-7561; shengai.li@uth.tmc.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT06029062
• Other Study ID Numbers: HSC-MS-22-0046 (Experiment 1)
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Sheng Li, The University of Texas Health Science Center, Houston
• Original Responsible Party: Same as current
• Current Study Sponsor: The University of Texas Health Science Center, Houston
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sheng Li, MD, Ph.D; The University of Texas Health Science Center, Houston

• PRS Account: The University of Texas Health Science Center, Houston
• Verification Date: May 2024