Investigating the Effects of Transcranial Stimulation to Advance Stroke Rehabilitation (T-STAR)

March 4, 2025 updated by: University of Oxford

Investigating the Effects of Beta Transcranial Stimulation to Advance Stroke Rehabilitation

Non-invasive brain stimulation (NIBS) has the potential to boost rehabilitation after stroke by creating a 'pro-plastic' environment, where the brain is more adaptable in response to movement (motor) training. However, responses to classical NIBS protocols are highly variable.

Movement-related changes in specific brain rhythms have previously been shown to be related to recovery of hand/arm function after a stroke. The investigators propose to use NIBS to target movement-related activity in the beta band (13-30Hz) within the motor cortical regions of the brain. The investigators will use a type of NIBS called transcranial alternating current stimulation (tACS), which uses a sinusoidally-varying electrical current where the stimulation frequency is determined to be relevant to the underlying brain rhythms of interest, and the stimulation timed to coincide with specific phases of the hand/arm movement.

The primary aim is to investigate whether beta-tACS improves upper limb movement in stroke survivors.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Stroke is a leading cause of death and long-term disability worldwide. More than 70% of stroke survivors experience motor impairments, often resulting in difficulties in daily activities, such as walking, reaching and grasping objects. Regaining upper-limb motor function is key to quality of life and for reducing the high annual costs due to stroke.

Research indicates that upper-limb motor function recovery depends on the plasticity of neural circuits controlling movement. Beta activity (β, ~13-30 Hz) in the sensorimotor cortex has been associated with brain plasticity and has been proposed to play a pivotal role in human movement and movement disorders. This activity attenuates during movement execution, known as event-related desynchronization (β-ERD), and temporarily increases after the end of movement, known as event-related synchronization (β-ERS).

β-ERD and β-ERS are reliably observed during active and passive movement, movement imagination and movement observation. Changes in movement-related β-ERD and β-ERS have been linked to motor learning, and motor dysfunction in neurological conditions, such as stroke. Studies have shown that stroke survivors with upper limb impairments exhibit significantly lower beta activity compared to healthy individuals, and recovery-related improvements in motor function are accompanied by increases in both sensorimotor β-ERD and β-ERS.

Therefore, modulation of movement-related beta activity (i.e., β-ERD and β-ERS) holds great promise for promoting motor function after stroke. Non-invasive brain stimulation (NIBS) can be applied during movements to increase plasticity and enhance motor learning and function. However, prior studies have delivered NIBS using a relatively broad approach; modulating general cortical excitability rather than enhancing specific endogenous oscillations in the brain. Transcranial alternating current stimulation (tACS) is a safe and well-tolerated type of NIBS which provides an option for modulating specific frequencies of brain oscillations by delivering a low-intensity sinusoidal electrical current to the brain at a specific frequency.

Therefore, this study will deliver beta-tACS to the ipsilesional motor cortex (M1) aiming to modulate sensorimotor beta activity during upper limb movement in stroke survivors. This study will investigate whether functionally timed beta-tACS has the potential to enhance motor recovery, by assessing whether stimulation delivered at the end of the movement improves upper limb movement (accuracy, smoothness and hand function) and increases the modulation of beta activity. Additionally, the investigators will evaluate whether the effectiveness of the stimulation relates to baseline neuroimaging and neurophysiological measures. Identifying correlates of intervention responsiveness will help future studies to target patients who are most likely to benefit.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Oxford, United Kingdom, OX3 9DU
        • Recruiting
        • Oxford Centre for Functional MRI of the Brain (FMRIB)
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participant is willing and able to give informed consent for participation in the study.
  • Aged 18 years or above.
  • Clinical diagnosis of stroke affecting the upper limb, with sufficient ability to perform the upper limb reaching task.
  • At least 3 months post-stroke and discharged from inpatient care.

Exclusion Criteria:

  • Inability to follow task instructions.
  • Other neurological condition affecting movement (e.g. Parkinson's Disease, Multiple Sclerosis).
  • Standard contraindications to non-invasive brain stimulation (TMS, tACS). including (but not limited to) the presence of intracranial metallic or magnetic hardware, seizures, pregnancy, and the presence of a pacemaker or other stimulators/implants.
  • Insufficient verbal and written English to comprehend the study and provide informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Stimulation (beta-tACS)
Participants will receive one session of active stimulation (beta-tACS) to the ipsilesional hemisphere. The electrode montage will include one electrode positioned on the scalp over the left or right motor cortex (either C3 or C4 using the international 10-20 EEG system), depending on the location of the stroke, and a second electrode over posterior area (Pz). A low intensity of stimulation (max. 4 mA peak to peak amplitude) will be used for up to 30 minutes in total (delivered in short bouts of up to 5 seconds based on the timing of movement of the upper limb).
Other: Transcranial Alternating Current Stimulation (beta-tACS)

The study intervention is transcranial alternating current stimulation (tACS).

The electrode montage will include one electrode positioned on the scalp over the left or right motor cortex (either C3 or C4 using the international 10-20 EEG system), depending on the location of the stroke, and a second electrode over posterior area (Pz). A low intensity of stimulation (max. 4 mA peak to peak amplitude) will be used for up to 30 minutes in total (delivered in short bouts of up to 5 seconds based on the timing of movement of the upper limb).

Other Names:
  • Non Invasive Brain Stimulation
  • beta tACS
Sham Comparator: Sham Stimulation (tACS)
Participants will receive one session of sham stimulation. The electrode placement will be the same as for the experimental condition, but duration or timing of stimulation will be insufficient to induce intended brain rhythm changes.
Other: Transcranial Alternating Current Stimulation (sham)
The comparator is sham stimulation. Stimulation is delivered for a very short duration or timed in such a way relative to movement to mimic the scalp sensations of the active stimulation without delivering stimulation that would be anticipated to impact relevant brain activity rhythms.
Other Names:
  • tACS (sham)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reaching Performance
Time Frame: From the first stimulation session to the completion of the third and final session, an average of 1 month
Performance on the reaching task, assessed using a motion sensor as the error (deviation from the ideal path) in cubic centimeters. Higher numbers indicate worse error/reaching performance.
From the first stimulation session to the completion of the third and final session, an average of 1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Movement-related Brain Rhythms
Time Frame: From the first stimulation session to the completion of the third and final session, an average of 1 month
Movement-related beta activity measured using electroencephalography (EEG), as power in decibels. Higher values indicate stronger (better) movement-related beta activity.
From the first stimulation session to the completion of the third and final session, an average of 1 month
Hand Function
Time Frame: From the first stimulation session to the completion of the third and final session, an average of 1 month
Change in hand function measured with the Box and Blocks Test from pre-stimulation to post-stimulation. Box and blocks test performance is measured as the number of blocks moved with the affected hand in 1 minute, higher numbers indicate better hand function.
From the first stimulation session to the completion of the third and final session, an average of 1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Smoothness of reaching movement (peaks)
Time Frame: From the first stimulation session to the completion of the third and final session, an average of 1 month
Smoothness of reaching movement assessed using a motion sensor as the number of peaks (number). Higher values indicate worse smoothness of reaching movement.
From the first stimulation session to the completion of the third and final session, an average of 1 month
Smoothness of reaching movement (arrest periods)
Time Frame: From the first stimulation session to the completion of the third and final session, an average of 1 month
Smoothness of reaching movement assessed using a motion sensor as the time of arrest periods (seconds). Higher numbers indicate worse smoothness of movement.
From the first stimulation session to the completion of the third and final session, an average of 1 month
Smoothness of reaching movement (Jerk)
Time Frame: From the first stimulation session to the completion of the third and final session, an average of 1 month
Smoothness of reaching movement assessed using a motion sensor as the jerk metric (time rate of change in acceleration) in centimeters per second. Lower values indicate better smoothness of reaching movement.
From the first stimulation session to the completion of the third and final session, an average of 1 month
Brain Structure at baseline (grey matter volume)
Time Frame: baseline
Brain structure measured with magnetic resonance imaging at baseline as the volume of grey matter in the motor-related areas of the ipsilesional hemisphere of the brain. Higher numbers indicate greater grey matter (brain) volume.
baseline
Brain Function at Baseline (connectivity)
Time Frame: baseline
Brain function measured with resting state functional magnetic resonance imaging at baseline. Higher numbers indicate greater functional brain connectivity.
baseline
Brain Function (neurochemicals) at Baseline
Time Frame: baseline
Brain function measured with magnetic resonance spectroscopic imaging as the concentration of neurochemicals GABA and Glutamate in the sensorimotor regions of interest. Higher numbers indicate a greater neurochemical concentration.
baseline
Corticospinal tract integrity at Baseline
Time Frame: baseline
Corticospinal tract integrity measured as the presence or absence of a motor evoked potential in the affected upper limb using transcranial magnetic stimulation at baseline (binary yes=1, no-0). A score of 1(yes) indicates a (at least partially) intact corticospinal tract.
baseline
Motor Ability at Baseline (Action Research Arm Test)
Time Frame: baseline
Motor ability assessed with the Action Research Arm Test, score 0-57. Higher numbers indicate better upper limb motor ability
baseline
Motor Impairment at Baseline (Fugl Meyer Assessment)
Time Frame: baseline
Upper Limb Motor impairment assessed with the Fugl Meyer Assessment, score 0-66. Higher numbers indicate less upper limb motor impairment
baseline
Brain Structure at baseline (grey matter damage)
Time Frame: baseline
Brain structure measured with magnetic resonance imaging at baseline as the percentage (%) of regions (parcels) damaged by the lesion. Higher numbers indicate greater grey matter (brain) damage.
baseline
Brain Structure at baseline (white matter damage)
Time Frame: baseline
Brain structure measured with magnetic resonance imaging at baseline as the percentage (%) of regions (tracts) disconnected due to the lesion. Higher numbers indicate greater white matter (brain) damage.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oxford

Investigators

  • Principal Investigator: Charlotte J Stagg, PhD, University of Oxford
  • Study Director: Catharina Zich, PhD, University of Oxford

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Study Registration Dates

First Submitted

October 23, 2024

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 4, 2025

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PID17878

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be available on reasonable request to the Chief Investigator, Dr Fleming or Dr Zich.

IPD Sharing Time Frame

After publication of the results. There is no definitive end date

IPD Sharing Supporting Information Type

  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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