Investigating the Use of a Brain-computer Interface Based on TMS Neurofeedback for Upper Limb Stroke Rehabilitation

NCT06164912 | Unknown Phase 1

• 1 other identifier: HRB-EIA-2019-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The mechanisms and effectiveness of a technique to boost the brain's recovery mechanisms will be studied. Brain-Computer Interface (BCI),based on applying magnetic pulses (Transcranial Magnetic Stimulation, TMS) to the stroke damaged area in the brain, causing twitches in the paralysed muscles will be used. The size of these twitches are then displayed to the patient as neurofeedback (NF) on a computer screen in the form of a game. In the game, the aim for the patient is to learn how to make the twitches bigger by engaging appropriate mental imagery to re-activate the damaged brain region.

Conditions

Transcranial Magnetic Stimulation; Stroke; Stroke Rehabilitation; Upper Extremity Paresis

Outcome Measures

Primary Outcomes (8)

• Fugl Meyer

  assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. Scoring is based on direct observation of performance. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible scale score is 226.

  pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.

• The National Institutes of Health Stroke Scale

  to measure stroke-related neurological deficit.The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible

  pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.

• Action research arm test

  assess upper extremity performance (coordination, dexterity and functioning). Scores on the ARAT may range from 0-57 points, with a maximum score of 57 points indicating better performance.

  pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.

• Oxford Cognitive Screen

  assess Language, Praxis, Number, Memory, Spatial and Controlled Attention. Each domain is scored separately and has a specific total.

  pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.

• Sleep questionnaire

  28 items. Four-point, Likert-type scale, respondents indicate how frequently they exhibit certain sleep behaviors (0 = "few," 1 = "sometimes," 2 = "often," and 3 = "almost always"

  pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.

• Mental imagery questionnaire

  2 items. 5-point, Likert-type scale, respondents indicate how vivid their visual and kinesthetic motor imagery is. Visual: 5 - image as clear as seeing,4 - clear image,3 -moderately clear image 2 - blurred image,1 - no image. Kinesthetic - How well can you feel opening and closing your paretic hand? 5 - as intense as executing the action, 4 - intense 3 - moderately intense, 2 - mildly intense 1 - no sensation.

  pre intervention, post intervention (within 3 days maximum), 2 weeks post intervention, 6 weeks post, 12 weeks post, 24 weeks post.

• Grey matter MRI Scan

  High-Resolution T1 Anatomical Scans (Grey matter) which will show concentration of tissue with high fat content (grey matter) to demonstrate brain anatomy. We will see if there are any structural brain changes before and after the TMS intervention.

  Baseline pre beginning TMS sessions. 6 months post last TMS sessions

• White matter MRI scan

  Diffusion Tensor Imaging Scans for imaging the concentration of white matter of the brain. We will see if there are any structural brain changes before and after the TMS intervention.

  Baseline pre beginning TMS sessions. 6 months post last TMS sessions

Study Arms (2)

TMS Neurofeedback

ACTIVE COMPARATOR

Participants in this Arm will receive TMS neurofeedback

Other: Transcranial Magnetic Simulation with Neurofeedback

TMS Pseudofeedback

PLACEBO COMPARATOR

Participants in this Arm will receive TMS with pseudofeedback

Other: Transcranial Magnetic Simulation with Pseudofeedback

Interventions

Transcranial Magnetic Simulation with Pseudofeedback OTHER

Participants will receive TMS with bogus feedback that will be displayed on a screen as they imagine movement.

TMS Pseudofeedback

Transcranial Magnetic Simulation with Neurofeedback OTHER

Participants will receive TMS with live Neurofeedback that will be displayed on a screen for them as they are imagining movement

TMS Neurofeedback

Eligibility Criteria

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

You may qualify if:

• Be in the sub-acute phase (2-26 weeks) post stroke.
• Single hemisphere lesion
• No previous transient ischemic attack (TIA)
• Upper limb functional impairment (0-2 power)
• No or negligible OCS broken hearts test score (visual neglect)
• No or almost no cognitive impairment (Pass or near pass MMSE and MOCA)
• Passes TMS-Safety Questionnaire
• Detectable motor evoked potential (MEP) in response to TMS

You may not qualify if:

• History of neuromuscular, neurological or active psychiatric disease (as these conditions and their respective medications may influence corticomotor excitability).
• History of anxiety-induced fainting. Patients with a history of anxiety induced fainting are at a small risk of fainting due to taking part in the study or hearing the 'clicking' sound produced by the TMS coil discharging.
• History of reaction or allergy to equipment or the skin preparation gel used to clean the skin surface prior to placing EMG electrodes. While allergic reaction to any of the materials used us very unlikely, any participants with history of adverse reaction to the environments or materials used (or similar) will be excluded to protect their wellbeing and prevent distress.
• Use of illicit drugs or other neurotransmission-altering drugs. These influence the brain and hence may impact upon the TMS or MRI measurements.
• Consumption of alcohol on the night preceding the recordings- to avoid potential influence of residual alcohol on neural network activity.
• Insufficient sleep on the night preceding the recording to prevent participants falling asleep or dozing during the recording, which would influence task performance. This is also in keeping with the guidelines of Rossi et al (2009).
• Eating very little in the 6 hours preceding the study- to avoid weakness or faintness.
• Any medical condition associated with neuropathy (eg.diabetes), seizure disorder, brain tumours, structural brain diseases, other degenerative brain diseases and other comorbidities (e.g human immunodeficiency virus). This is to prevent abnormal neural activity generating data related to something other than that of the diagnosis under study (stroke).
• Any head trauma injury associated with loss of consciousness.
• Regular, severe headaches
• Noise induced hearing loss, or ringing in the ears.
• Possible pregnancy
• Implanted Neurostimulator
• Anxiety in Hospital settings

Sponsors & Collaborators

• University of Dublin, Trinity College: lead
• St. James Hospital: collaborator

Study Sites (1)

St James' Hospital

Dublin, Leinster, D08 NHY1, Ireland

RECRUITING

Related Publications (3)

• Byblow WD, Stinear CM, Barber PA, Petoe MA, Ackerley SJ. Proportional recovery after stroke depends on corticomotor integrity. Ann Neurol. 2015 Dec;78(6):848-59. doi: 10.1002/ana.24472. Epub 2015 Nov 17.

  PMID: 26150318 RESULT

• Ruddy K, Balsters J, Mantini D, Liu Q, Kassraian-Fard P, Enz N, Mihelj E, Subhash Chander B, Soekadar SR, Wenderoth N. Neural activity related to volitional regulation of cortical excitability. Elife. 2018 Nov 29;7:e40843. doi: 10.7554/eLife.40843.

  PMID: 30489255 RESULT

• Liang WD, Xu Y, Schmidt J, Zhang LX, Ruddy KL. Upregulating excitability of corticospinal pathways in stroke patients using TMS neurofeedback; A pilot study. Neuroimage Clin. 2020;28:102465. doi: 10.1016/j.nicl.2020.102465. Epub 2020 Oct 13.

  PMID: 33395961 RESULT

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Neurofeedback

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

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Joe Harbison, MD

  St. James' Hospital Dublin

  STUDY DIRECTOR

Central Study Contacts

Kathy Ruddy, PhD

CONTACT

+44 7481811676; k.ruddy@qub.ac.uk

Lamia Tadjine, MSc

CONTACT

+353 877623029; ltadjine@tcd.ie

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: One research assistant will carry out the TMS neurofeedback or pseudofeedback on the patient, the other will conduct the functional tests on the patient so as to not bias the scoring of the functional tests.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: Participants will undergo transcranial magnetic stimulation (TMS) neurofeedback (NF) incorporated into a computer game that is tailored to train the individuals to produce larger than baseline motor evoked potentials (MEPs) in the stroke affected limb, by practising and engaging different mental imagery strategies. Pulses of TMS will be applied over the motor cortex of the stroke affected hemisphere, resulting in MEPs that will be recorded from the target muscles of the stroke affected limb.The brain computer interface (BCI) will process the amplitude of these MEPs in real-time, and will display this information on screen to the patient in the form of a game, where their goal is to push a rectangular bar (MEP amplitude) over the line (baseline amplitude when resting).

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: December 11, 2023
• Study Start: June 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)