Efficacy of EMF BCI Based Device on Acute Stroke

NCT04039178 | Terminated

• 1 other identifier: BQ3
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The study tests the efficacy of a non-invasive device with low intensity electromagnetic field dedicated treatment to enhance the recovery of stroke patients impaired hand motor function

Conditions

Acute Stroke

Keywords

BCI; BQ; motor function; acute stroke; EMF

Outcome Measures

Primary Outcomes (1)

• Fugl Meyer Assessment of Upper Extremity (FMA-UE)

  FMA score of upper limb, range between 0 to 66 (higher the better)

  Two months

Secondary Outcomes (9)

• ARAT

  two months

• BBT

  two months

• TMT

  two months

• NIHSS

  two months

• Promis 10

  two months

Study Arms (2)

Treatment group

ACTIVE COMPARATOR

Real BQ treatment, 40 treatments including 20 minutes of device guided functional motor tasks.

Device: BQ

Control group

SHAM COMPARATOR

Sham BQ treatment, (zero intensity) 40 treatments including 20 minutes of device guided functional motor tasks.

Device: Sham

Interventions

BQ DEVICE

The BQ device (BrainQ Technologies Ltd., Israel), a Brain Computer Interface based stimulation device, uses machine learning tools to identify high resolution spectral patterns associated with motor functions in EEG measurements of healthy/non healthy subjects. These patterns are then translated into a tailored frequency dependent low intensity, non-invasive electro-magnetic treatment protocol.

Also known as: Formerly VLIFE

Treatment group

Sham DEVICE

Sham BQ device

Control group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of 1st ever ischemic stroke confirmed by imaging or 1st recurrent ischemic stroke with no previous neurological impairment in the same limb before current stroke happened
• h to 15 days from stroke onset or 21 days from stroke onset in case the patient was still unstable at day 15 from stroke onset).
• Medically stable patients
• Age: \> 18, \<80 years, and independent in their daily activities before the stroke
• Right dominant hand
• FM \>10, \<45 of upper tested limb.
• Able to sit in a chair for 70 consecutive minutes and follow three verbal instructions:
• Bring your healthy arm to the level of your shoulder
• Pick up this pen with your healthy hand.
• Put your healthy hand on your waist
• Able to understand the information provided and provide informed consent

You may not qualify if:

• Contraindication for performing MRI scanning
• History of recent epileptic seizures or epilepsy and/or currently taking medication that are known to lower the seizure threshold
• Patients with an acute problem such as active infection at the time of recruitment for research
• Previous disease of the central nervous system
• Damage to the joints, bones and muscles causing restriction of movement of the upper limb being tested
• Patients known to suffer from some peripheral nerve damage of the upper limb that being tested
• Pregnant women and women who have the ability to become pregnant unless they are on an acceptable method of contraception during the study.
• Alcoholism or drug addiction as defined by DSM-IV within last 5 years

Sponsors & Collaborators

• BrainQ Technologies Ltd.: lead

Study Sites (1)

BLK super specialty hospital

New Delhi, India

Location

Related Publications (1)

• Weisinger B, Pandey DP, Saver JL, Hochberg A, Bitton A, Doniger GM, Lifshitz A, Vardi O, Shohami E, Segal Y, Reznik Balter S, Djemal Kay Y, Alter A, Prasad A, Bornstein NM. Frequency-tuned electromagnetic field therapy improves post-stroke motor function: A pilot randomized controlled trial. Front Neurol. 2022 Nov 14;13:1004677. doi: 10.3389/fneur.2022.1004677. eCollection 2022.

  PMID: 36452175 DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Dharam P Pandey, PhD

  BLK hospital , New Delhi , India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sham device appears as real device. Only randomizer which is a third party, is unblinded. First 4 patients are non randomized
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, double blinded, sham device controlled study

Study Record Dates

• First Submitted: July 29, 2019
• First Posted: July 31, 2019
• Study Start: September 4, 2018
• Primary Completion: March 21, 2020
• Study Completion: March 21, 2020
• Last Updated: February 11, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)