Transcranial Alternating Current Stimulation (tACS) to Improve Motor Skill Acquisition in Stroke Patients

NCT05576129 | Completed

• 1 other identifier: CFC_tACS_Stroke
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Hand motor function is often severely affected in stroke patients and its recovery is one primary goal in stroke rehabilitative treatment programs. Recently, theta-gamma transcranial alternating current stimulation (tACS) has been shown to enhance motor skill acquisition in healthy individuals. The aim of the present study is to examine the effect of theta-gamma tACS on motor skill acquisition in chronic stroke patients.

Conditions

Stroke

Keywords

Stroke; Hand motor impairment; Transcranial alternating current stimulation; Non-invasive brain stimulation; motor learning; sensorimotor cortex; crossfrequency coupling; theta-gamma phase amplitude coupling

Outcome Measures

Primary Outcomes (1)

• Motor Skill Acquisition

  Quotient of mean "Duration of Button Presses" of the best block and the baseline block. Best block is defined as the block with the lowest mean "Duration of Button Presses". "Duration of Button Press" is the Duration between the first and fourth button press of a valid trial.

  Over the course of the motor task with a duration of 38 minutes and 20 seconds.

Secondary Outcomes (1)

• Duration of Button Presses

  Baseline (consisting of 20 trials) and each of 6 blocks (consisting of 40 trials each)

Other Outcomes (1)

• "Thumb Speed" and "Thumb Acceleration"

  Over the course of the motor task with a duration of 38 minutes and 20 seconds.

Study Arms (2)

TGP-tACS

ACTIVE COMPARATOR

Patients perform a motor skill acquisition task with the affected hand during TGP-stimulation over the sensorimotor cortex on the lesioned side.

Device: TGP-tACS

Sham-tACS

SHAM COMPARATOR

Patients perform a motor skill acquisition task with the affected hand during sham-stimulation over the sensorimotor cortex on the lesioned side.

Device: Sham-tACS

Interventions

TGP-tACS DEVICE

38 min and 20s of 4mA peak-to-peak theta-gamma stimulation with 75 Hz-gamma coupled to the peak of 6Hz-theta waves. 3s ramp-up at the beginning of stimulation and 3s ramp-down at the end of stimulation. Administered using a Starstim® device and 5 gel electrodes with a πcm² area.

TGP-tACS

Sham-tACS DEVICE

38 min and 20s of alternation between 10s of 4mA peak-to-peak TGP- tACS and a 6 min 30s stimulation-free interval. Each stimulation consists of 3s ramp-up, 4s TGP stimulation and 3s ramp-down. Administered using a Starstim® device and 5 gel electrodes with a πcm² area.

Sham-tACS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• German-speaking
• ability to perform a thumb movement task with the affected hand
• first-ever clinical ischemic stroke in the chronic phase
• persistent mild motor deficit of the upper extremity or motor deficit of the upper extremity in the acute phase over \>24h

You may not qualify if:

• pronounced cognitive deficits
• history of major neurological or psychiatric illness other than stroke
• epilepsy or epileptic seizure in the history
• any devices or implants in the head region (e.g. cochlear implant, aneurysm clips),
• implanted pacemaker or medical pumps
• intake of psychotropic medication
• allergy to any ingredient of the local anesthetic cream
• pregnancy

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead
• Technical University of Twente: collaborator
• University of Oxford: collaborator

Study Sites (1)

Department of Neurology, University Medical Center Hamburg-Eppendorf

Hamburg, 20246, Germany

Location

Related Publications (2)

• Akkad H, Dupont-Hadwen J, Kane E, Evans C, Barrett L, Frese A, Tetkovic I, Bestmann S, Stagg CJ. Increasing human motor skill acquisition by driving theta-gamma coupling. Elife. 2021 Nov 23;10:e67355. doi: 10.7554/eLife.67355.

  PMID: 34812140 BACKGROUND

• Grigutsch LS, Haverland B, Timmsen LS, Asmussen L, Braass H, Wolf S, Luu TV, Stagg CJ, Schulz R, Quandt F, Schwab BC. Differential effects of theta-gamma tACS on motor skill acquisition in young individuals and stroke survivors: A double-blind, randomized, sham-controlled study. Brain Stimul. 2024 Sep-Oct;17(5):1076-1085. doi: 10.1016/j.brs.2024.09.001. Epub 2024 Sep 6.

  PMID: 39245294 RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Fanny Quandt, Dr.

  Department of Neurology; University Medical Center Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Bettina Schwab, PhD

  Biomedical Signals and Systems, Technical Medical Centre, University of Twente, The Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 7, 2022
• First Posted: October 12, 2022
• Study Start: November 14, 2022
• Primary Completion: August 25, 2023
• Study Completion: August 25, 2023
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)