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First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
NA trial testing ECoG (electrocorticography) sensing in Locked-In Syndrome in 6 participants. Completed in 14 February 2024.
| Lead sponsor | UMC Utrecht |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 6 |
| Start date | 9 September 2015 |
| Primary completion | 14 February 2024 |
| Estimated completion | 14 February 2024 |
| Sites | 1 location across Netherlands |
UMC Utrecht — full company profile →
Adults 18 to 75, any sex, with Locked-In Syndrome. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The system correctly detects a switch brain signal within 10 sec in a real life, cognitively engaging context, such as operating a spelling device. A formal test has been designed, in which the patient has to copy a 30 character sentence within 30 minutes, with a margin of 20% faulty characters.
| Group | Value | 95% CI |
|---|---|---|
| ECoG (electrocorticography) sensing | 1 |
The Québec User Evaluation of Satisfaction with Assistive Technology (QUEST) 2.0, a self-report or interview-based scale, designed to evaluate a person's satisfaction with a wide range of assistive technology, consisting of a 12 questions scale from 1(very dissatisfied) - 4(very satisfied). Reported is mean score. Higher scores are better.
| Group | Value | 95% CI |
|---|---|---|
| ECoG (electrocorticography) sensing | 3.5 |
Psychosocial Impact of Assistive Devices Scale (PIADS), a 26-item, self-report questionnaire designed to assess the effects of an assistive device on functional independence, well-being, and quality of life. Score range is -3 to 3, larger values indicate a more positive effect of the device. Outcome is averaged over three domains (competence, adaptability, and self-esteem)
| Group | Value | 95% CI |
|---|---|---|
| ECoG (electrocorticography) sensing | 2.43 | -2 – 3 |
Anamnestic Comparative Self-Assessment (ACSA), a self-anchoring rating scale for subjective well-being score, ranges from -5 (worst period in life) to +5 (best period in life). Higher scores are a better outcome.
| Group | Value | 95% CI |
|---|---|---|
| ECoG (electrocorticography) sensing | 2 |
The hours of use of the BCI device as determined by logging within the home use software. Only hours of use with full featured home use software and appropriate signal amplitude. The period where signal amplitude declined, possibly due to participants disease progression, is not taken into account.
| Group | Value | 95% CI |
|---|---|---|
| ECoG (electrocorticography) sensing | 21.26 | 19 – 23.5 |
The patient is able to generate switch commands with at least 80 % correct, with the help of a BCI researcher and/or caregiver (using a formal test)
| Group | Value | 95% CI |
|---|---|---|
| ECoG (electrocorticography) sensing | 3 |
Time frame: 8.5 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | ECoG (electrocorticography… |
|---|---|---|
| disease related respiratory failure | Nervous system disorders | — |
| pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| fever | Infections and infestations | — |
| low oxygen | Respiratory, thoracic and mediastinal disorders | — |
| seizure | Nervous system disorders | — |
| Reaction | System | ECoG (electrocorticography… |
|---|---|---|
| Numbness in ear cup | Nervous system disorders | — |
| Decreased medical fitness | General disorders | — |
| High blood pressure, high heart rate and fever | Blood and lymphatic system disorders | — |
| Pneumonia | Respiratory, thoracic and mediastinal disorders | — |
| Hypotension, anemia and thrombocytopenia | General disorders | — |
| High inflammatory values | Infections and infestations | — |
| Hearing loss | Ear and labyrinth disorders | — |
| pain in the neck | Musculoskeletal and connective tissue disorders | — |
| Occasional jaw lock | Musculoskeletal and connective tissue disorders | — |
| Blister | Skin and subcutaneous tissue disorders | — |
| Bladder infection | Renal and urinary disorders | — |
| Lower well being | General disorders | — |
Most-reported serious reactions: disease related respiratory failure, pneumonia, fever, low oxygen, seizure.
Data from ClinicalTrials.gov NCT02224469 adverse events section.
In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Trials by the same sponsor.
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing