Trial Outcomes & Findings for First Study With a Brain Implant to Help Locked-in Patients Communicate at Home (NCT NCT02224469)

NCT ID: NCT02224469

Last Updated: 2025-12-03

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 6 participants
• Primary outcome timeframe: up to 1 year
• Results posted on: 2025-12-03

Participant Flow

Participant milestones

Measure	ECoG (electrocorticography) sensing Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Overall Study STARTED	6
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	ECoG (Electrocorticography) Sensing n=6 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Age, Continuous	56 years STANDARD_DEVIATION 9.2 • n=6 Participants
Sex: Female, Male Female	2 Participants n=6 Participants
Sex: Female, Male Male	4 Participants n=6 Participants

PRIMARY outcome

Timeframe: up to 1 year

Population: This is analyzed in the participants who received an implant

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.

Outcome measures

Measure	ECoG (electrocorticography) sensing n=3 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance	1 Participants

SECONDARY outcome

Timeframe: 8 years

Population: participant with home use

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.

Outcome measures

Measure	ECoG (electrocorticography) sensing n=1 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Patient Device Satisfaction	3.5 score on a scale

SECONDARY outcome

Timeframe: 3 years

Population: participant with home use

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)

Outcome measures

Measure	ECoG (electrocorticography) sensing n=1 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Effects Device on Quality of Life	2.43 score on a scale Interval -2.0 to 3.0

SECONDARY outcome

Timeframe: 4.5 years

Population: participant with home use

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.

Outcome measures

Measure	ECoG (electrocorticography) sensing n=1 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Quality of Life by Scoring Subjective Well-being in ACSA Score	2 score on a scale

SECONDARY outcome

Timeframe: Time frame starts when participant receives a system with the full feature set for 24h home use and ends when signal decline starts influencing hours of use per day, an average of 1 year

Population: participant with home use

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.

Outcome measures

Measure	ECoG (electrocorticography) sensing n=1 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Hours of Use of BCI Device Per Day	21.26 hours per day Interval 19.0 to 23.5

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 28 weeks

Population: only participants that received an implant

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)

Outcome measures

Measure	ECoG (electrocorticography) sensing n=3 Participants Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Supervised BCI Performance	3 Participants

Adverse Events

ECoG (electrocorticography) sensing

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Serious adverse events

Measure	ECoG (electrocorticography) sensing n=6 participants at risk Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Respiratory, thoracic and mediastinal disorders pneumonia	33.3% 2/6 • Number of events 2 • 8.5 years
Respiratory, thoracic and mediastinal disorders low oxygen	16.7% 1/6 • Number of events 1 • 8.5 years
Nervous system disorders seizure	16.7% 1/6 • Number of events 2 • 8.5 years
Infections and infestations fever	16.7% 1/6 • Number of events 1 • 8.5 years
Nervous system disorders disease related respiratory failure	33.3% 2/6 • Number of events 2 • 8.5 years

Other adverse events

Measure	ECoG (electrocorticography) sensing n=6 participants at risk Use ECoG-based Brain Computer interface to control assistive technology ECoG (electrocorticography) sensing: Implant electrodes and sensing device and use for control of Assistive Technology
Nervous system disorders Numbness in ear cup	16.7% 1/6 • Number of events 1 • 8.5 years
General disorders Decreased medical fitness	16.7% 1/6 • Number of events 1 • 8.5 years
Blood and lymphatic system disorders High blood pressure, high heart rate and fever	16.7% 1/6 • Number of events 1 • 8.5 years
Respiratory, thoracic and mediastinal disorders Pneumonia	16.7% 1/6 • Number of events 1 • 8.5 years
General disorders Hypotension, anemia and thrombocytopenia	16.7% 1/6 • Number of events 1 • 8.5 years
Infections and infestations High inflammatory values	16.7% 1/6 • Number of events 1 • 8.5 years
Ear and labyrinth disorders Hearing loss	16.7% 1/6 • Number of events 1 • 8.5 years
Musculoskeletal and connective tissue disorders pain in the neck	16.7% 1/6 • Number of events 2 • 8.5 years
Musculoskeletal and connective tissue disorders Occasional jaw lock	16.7% 1/6 • Number of events 1 • 8.5 years
Skin and subcutaneous tissue disorders Blister	16.7% 1/6 • Number of events 1 • 8.5 years
Renal and urinary disorders Bladder infection	16.7% 1/6 • Number of events 2 • 8.5 years
General disorders Lower well being	16.7% 1/6 • Number of events 1 • 8.5 years

Additional Information

Dr E.J. Aarnoutse

University Medical Center Utrecht

Phone: +31887555123

Email: e.j.aarnoutse@umcutrecht.nl

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place