Trial Outcomes & Findings for Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease (NCT NCT03623386)

Last Updated: 2024-02-15

Results Overview

The functional connectivity strength between the subjects' right insula and dorsomedial frontal cortex will be measured at baseline and post-intervention as each group of subjects engages in their respective imagery tasks. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions.

Recruitment status

COMPLETED

Study phase

Target enrollment

63 participants

Primary outcome timeframe

4-6 weeks

Results posted on

2024-02-15

Participant Flow

Participant milestones

Participant milestones
Measure	Patients With PD Neurofeedback Training Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training. This was a small pilot arm with no intervention conducted after the completion of the study.
Overall Study STARTED	26	28	9
Overall Study COMPLETED	22	22	9
Overall Study NOT COMPLETED	4	6	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients With PD Neurofeedback Training Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
Overall Study Protocol Violation	3	2
Overall Study Physician Decision	1	1
Overall Study Lost to Follow-up	0	2
Overall Study COVID-19	0	1

Baseline Characteristics

Effect of Mental Imagery Training on Brain Plasticity and Motor Function in Individuals With Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With PD Neurofeedback Training n=22 Participants Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control n=22 Participants Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD n=9 Participants Patients perform mental imagery (motor and visual aspects combined) in the MRI scanner without neurofeedback training. This was a small pilot arm with no intervention conducted after the completion of the study.	Total n=53 Participants Total of all reporting groups
Age, Continuous	66.2 years STANDARD_DEVIATION 8.1 • n=5 Participants	65.7 years STANDARD_DEVIATION 8.8 • n=7 Participants	67.4 years STANDARD_DEVIATION 6.1 • n=5 Participants	66.2 years STANDARD_DEVIATION 8.0 • n=4 Participants
Sex: Female, Male Female	10 Participants n=5 Participants	10 Participants n=7 Participants	7 Participants n=5 Participants	27 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	12 Participants n=7 Participants	2 Participants n=5 Participants	26 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	22 Participants n=5 Participants	20 Participants n=7 Participants	9 Participants n=5 Participants	51 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	21 Participants n=7 Participants	9 Participants n=5 Participants	52 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	22 participants n=5 Participants	22 participants n=7 Participants	9 participants n=5 Participants	53 participants n=4 Participants

PRIMARY outcome

Timeframe: 4-6 weeks

Population: Complete case analyses and participants in the pilot PD arm did not have these data collected.

Outcome measures

Outcome measures
Measure	Patients With PD Neurofeedback Training n=22 Participants Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control n=22 Participants Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
Change in Right Insula-dorsomedial Frontal Cortex Functional Connectivity Strength.	93.2 percent change from baseline Standard Error 84.1	97.8 percent change from baseline Standard Error 106.6

PRIMARY outcome

Timeframe: 4-6 weeks

Population: Complete case analyses and participants in the pilot PD arm did not have these data collected.

We will obtain resting-state functional MRI scans from the PD-neurofeedback and PD-control groups at baseline and post-intervention to examine the changes in intrinsic functional connectivity between the right insula and dorsomedial frontal cortex. Functional connectivity will be measured as the correlation value between the functional MRI signal time courses obtained from these two brain regions.

Outcome measures

Outcome measures
Measure	Patients With PD Neurofeedback Training n=22 Participants Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control n=22 Participants Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
Change in Resting-state Functional Connectivity Between the Right Insula and Dorsomedial Frontal Cortex.	-2.9 percent change from baseline Standard Error 43.7	74.2 percent change from baseline Standard Error 58.8

PRIMARY outcome

Timeframe: Baseline and 4-6 weeks

Population: Complete case analyses and participants in the pilot PD arm did not have these data collected.

We will administer the Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III (motor exam) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor impairment. The MDS-UPDRS part III is a subscale that provides an objective assessment of motor impairment. The scores range between 0-132. Higher scores indicate more severe impairment.

Outcome measures

Outcome measures
Measure	Patients With PD Neurofeedback Training n=22 Participants Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control n=22 Participants Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
Change in Motor Impairment Pre	32.3 score on a scale Standard Deviation 8.1	34.5 score on a scale Standard Deviation 9.6
Change in Motor Impairment Post	31.3 score on a scale Standard Deviation 9.8	35.1 score on a scale Standard Deviation 10.8

PRIMARY outcome

Timeframe: Baseline and 4-6 weeks

Population: Complete case analyses and participants in the pilot PD arm did not have these data collected.

We will administer standard motor function tests (e.g., timed up and go, 5 times sit-to-stand, 360-degree turn) at baseline and post-intervention to the PD-neurofeedback and PD-control groups to measure the change in motor function. The performance score on these tests is the time to complete the motor tasks. Shorter time indicates better performance. The motor function tests measure movement speed. Timed up and go test measures (seconds) how fast one can stand up from a chair, walk 3 meters, turn, walk back to the chair and sit down again. Five times sit-to-stand test measures (seconds) how fast one can stand up from a chair with arms crossed across the chest and sit back again 5 times in a row. 360-degree turn test measures (seconds) how fast one can turn around their own axis clockwise and counterclockwise. The composite motor function score is the sum of the durations (seconds) of all three tests.

Outcome measures

Outcome measures
Measure	Patients With PD Neurofeedback Training n=22 Participants Patients will receive neurofeedback training. PD neurofeedback: PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.	Patients With PD Control n=22 Participants Patients will not receive neurofeedback training. PD control: PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
Change in Motor Function Pre	23.7 seconds Standard Deviation 4.7	24.4 seconds Standard Deviation 4.9
Change in Motor Function Post	22.3 seconds Standard Deviation 5.1	24.1 seconds Standard Deviation 5.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 day

In a group of PD patients who will not receive any intervention, we will collect functional MRI data during a mental imagery task with both motor and visual imagery components to investigate the functional connectivity between the motor and visual networks.

Outcome measures

Outcome data not reported

Adverse Events

Patients With PD Neurofeedback Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With PD Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patients With PD

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

Sule Tinaz, MD, PhD: Associate Professor of Neurology

Yale School of Medicine

Phone: (877) 925-3637

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place