Trial Outcomes & Findings for Neurofeedback for Stroke Rehabilitation (NCT NCT03775915)

Results Overview

Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

27 participants

Primary outcome timeframe

Throughout the 3 intervention sessions, an average of 4 days

Results posted on

2023-06-13

Participant Flow

Participants were recruited from the community, between February 2018 and March 2020

3 participants were not randomised to a group. 1 was withdrawn because the location of their stroke lesion made it impossible to deliver the intervention. 1 withdrew because they did not like the MRI scan. 1 was unable to continue due to study suspension because of the coronavirus pandemic.

Participant milestones

Participant milestones
Measure	Real Neurofeedback 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Overall Study STARTED	12	12
Overall Study COMPLETED	12	12
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Real Neurofeedback n=12 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=12 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant	Total n=24 Participants Total of all reporting groups
Age, Continuous	64 years STANDARD_DEVIATION 11 • n=12 Participants	59 years STANDARD_DEVIATION 13 • n=12 Participants	62 years STANDARD_DEVIATION 12 • n=24 Participants
Sex: Female, Male Female	4 Participants n=12 Participants	1 Participants n=12 Participants	5 Participants n=24 Participants
Sex: Female, Male Male	8 Participants n=12 Participants	11 Participants n=12 Participants	19 Participants n=24 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	12 participants n=12 Participants	12 participants n=12 Participants	24 participants n=24 Participants
Affected Hand Right	2 Participants n=12 Participants	6 Participants n=12 Participants	8 Participants n=24 Participants
Affected Hand Left	10 Participants n=12 Participants	6 Participants n=12 Participants	16 Participants n=24 Participants
Time since stroke	79 months STANDARD_DEVIATION 70 • n=12 Participants	72 months STANDARD_DEVIATION 63 • n=12 Participants	76 months STANDARD_DEVIATION 65 • n=24 Participants

PRIMARY outcome

Timeframe: Throughout the 3 intervention sessions, an average of 4 days

Lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal. The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=12 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=12 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Lateralisation of Brain Activity Day 2	0.23 laterality index adjusted for baseline Interval 0.15 to 0.31	0.30 laterality index adjusted for baseline Interval 0.22 to 0.39
Lateralisation of Brain Activity Day 3	0.26 laterality index adjusted for baseline Interval 0.17 to 0.34	0.22 laterality index adjusted for baseline Interval 0.13 to 0.31
Lateralisation of Brain Activity Day 4	0.25 laterality index adjusted for baseline Interval 0.17 to 0.34	0.25 laterality index adjusted for baseline Interval 0.16 to 0.34

PRIMARY outcome

Timeframe: Throughout study completion, 5 assessment sessions spread over approximately 3 weeks

Performance on the Jebsen Taylor hand function test (time, in seconds to complete specified activities reflecting daily living)

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=12 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=12 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds) Day1	267 seconds Standard Error 73	274 seconds Standard Error 77
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds) Day2	238 seconds Standard Error 64	270 seconds Standard Error 77
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds) Day3	221 seconds Standard Error 59	267 seconds Standard Error 75
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds) Day4	220 seconds Standard Error 61	233 seconds Standard Error 64
Hand Function Assessed With the Jebsen Taylor Hand Function Test (Time, in Seconds) Day5	214 seconds Standard Error 61	249 seconds Standard Error 70

SECONDARY outcome

Timeframe: 1 week follow up

Change in lateralisation of brain activity during movement of the affected hand, assessed using functional magnetic resonance imaging (fMRI) blood oxygen level dependent (BOLD) signal.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 week follow up

Population: Outliers removed on the basis of head motion or laterality index greater than 2 standard deviations from the mean

Lateralisation of brain activity during a visuomotor squeeze task, assessed using functional magnetic resonance imaging (BOLD signal). The activation in the region of interest is calculated for each hemisphere and the laterality index calculated as: (ipsilesional hemisphere - contralesional hemisphere) / (ipsilesional hemisphere + contralesional hemisphere). As such, positive values are indicative of greater activation in the ipsilesional hemisphere.

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=10 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=9 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI) Baseline	0.31 laterality index Standard Error 0.03	0.21 laterality index Standard Error 0.06
Lateralisation of Brain Activity During Visuomotor Squeeze Task (MRI) 1 week follow up	0.29 laterality index Standard Error 0.03	0.28 laterality index Standard Error 0.05

SECONDARY outcome

Timeframe: Throughout study completion, an average of 3 weeks

Change in lateralisation of brain activity during a visuomotor squeeze task, assessed using EEG

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, 1 week follow up

Action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=12 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=12 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Upper Limb Function Baseline	31.9 score on a scale Standard Error 3.5	35.3 score on a scale Standard Error 3.9
Upper Limb Function 1 week follow up	34.3 score on a scale Standard Error 3.7	35.8 score on a scale Standard Error 3.7

SECONDARY outcome

Timeframe: 1 month follow up

Population: Only participants who were able to attend the 1 month follow up are included

Change in action research arm test score (ARAT; upper limb function). Range 0-57, higher numbers indicate better upper limb function

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=7 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=10 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Change in Upper Limb Function Baseline	31.7 score on a scale Standard Error 5.5	38.3 score on a scale Standard Error 3.9
Change in Upper Limb Function 1 month follow up	34.7 score on a scale Standard Error 5.7	38.5 score on a scale Standard Error 3.4

SECONDARY outcome

Timeframe: Baseline, 1 week follow up

Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=12 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=12 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Upper Limb Impairment Baseline	44.2 score on a scale Standard Error 2.9	44.3 score on a scale Standard Error 4.0
Upper Limb Impairment 1 week follow up	45.8 score on a scale Standard Error 2.2	46.3 score on a scale Standard Error 3.5

SECONDARY outcome

Timeframe: Baseline, 1 month follow up

Population: Only participants who were able to attend the 1 month follow up are included

Upper limb Fugl Meyer assessment score (upper limb impairment). Range 0-66, higher numbers indicate less upper limb impairment

Outcome measures

Outcome measures
Measure	Real Neurofeedback n=7 Participants 3 sessions of Real Neurofeedback over 1 week Neurofeedback: A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.	Sham Neurofeedback n=10 Participants 3 sessions of Sham Neurofeedback over 1 week Sham Neurofeedback: A visual representation of brain activity pre-recorded from a previous participant
Upper Limb Impairment Baseline	45.7 score on a scale Standard Error 3.9	46.2 score on a scale Standard Error 4.5
Upper Limb Impairment 1 month follow up	46.6 score on a scale Standard Error 3.9	47.7 score on a scale Standard Error 3.8

Adverse Events

Real Neurofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham Neurofeedback

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Melanie Fleming, Research Associate

University of Oxford

Phone: +441865611461

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place