Trial Outcomes & Findings for Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments (NCT NCT05174949)

Last Updated: 2024-07-29

Results Overview

The Fugl-Meyer Upper Extremity (FM-UE) subset is a component of the Fugl-Meyer Assessment (FM) assessing motor impairment in individuals with stroke or other arm impairments. The (FM-UE) subset focuses on evaluating motor impairment and recovery using movements assessing strength, coordination, sensation, and range of motion of the upper extremity. Each item in the FM-UE subset is scored on a scale from 0-2. These are added together, with higher scores indicating better motor function. The FM-UE subset has 33 items for a maximum possible (highest functioning) score of 66.

Recruitment status

COMPLETED

Study phase

Target enrollment

14 participants

Primary outcome timeframe

The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). .

Results posted on

2024-07-29

Participant Flow

Our primary patient resource is from OU Physician Neurology Clinic and Allied Health Clinical Network. We also seek referrals from clinicians in the Oklahoma City areas and recruit stroke survivors residing in these two areas who wish to participate in the study. The recruitment method include doctor referrals and direct contact (if study doctor's patients) via the study doctor. Recruitment period: 1/18/2022-5/12/2023

Stroke participants will be examined by the study doctor to verify their admissibility to the study based on the inclusion criteria. Participants will then undergo the upper extremity portion of the Fugl-Meyer Motor Assessment, and a structured interview pertaining to the inclusion criteria.

Participant milestones

Participant milestones
Measure	Sham, Anodal, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins) with 2-week wash-out period: 1. sham 2. anodal stimulation over the ipsilesional primary motor cortex 3. cathodal one over the contralesional premotor cortex	Anodal, Cathodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. sham	Cathodal, Sham, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. cathodal one over the contralesional premotor cortex 2. sham 3. anodal stimulation over the ipsilesional primary motor cortex	Sham, Cathodal, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. sham 2. cathodal one over the contralesional premotor cortex 3. anodal stimulation over the ipsilesional primary motor cortex	Cathodal, Anodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. cathodal one over the contralesional premotor cortex 2. anodal stimulation over the ipsilesional primary motor cortex 3. sham	Anodal, Sham, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham
Overall Study STARTED	1	4	1	5	2	1
Overall Study Per-protocol (PP) Population	1	4	1	4	2	1
Overall Study COMPLETED	0	1	1	3	2	1
Overall Study NOT COMPLETED	1	3	0	2	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sham, Anodal, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins) with 2-week wash-out period: 1. sham 2. anodal stimulation over the ipsilesional primary motor cortex 3. cathodal one over the contralesional premotor cortex	Anodal, Cathodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. sham	Sham, Cathodal, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. sham 2. cathodal one over the contralesional premotor cortex 3. anodal stimulation over the ipsilesional primary motor cortex
Overall Study Physician Decision	1	2	1
Overall Study Withdrawal by Subject	0	1	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

Targeted High-definition Transcranial Direct Current Stimulation (HD-tDCS) for Reducing Post-stroke Movement Impairments

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham, Anodal, Cathodal n=1 Participants Treatment order 1: Sham, Anodal, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham	Anodal, Cathodal, Sham n=4 Participants Treatment order 2: Anodal, Cathodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham	Cathodal, Sham, Anodal n=1 Participants Treatment order 3: Cathodal, Sham, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham	Sham, Cathodal, Anodal n=4 Participants Treatment order 4: Sham, Cathodal, Anodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham	Cathodal, Anodal, Sham n=2 Participants Treatment order 5: Cathodal, Anodal, Sham Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham	Anodal, Sham, Cathodal n=1 Participants Treatment order 6: Anodal, Sham, Cathodal Transcranial direct current stimulation (high-definition): Three conditions (2 mA, 20 mins): 1. anodal stimulation over the ipsilesional primary motor cortex 2. cathodal one over the contralesional premotor cortex 3. Sham	Total n=13 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 0 • n=5 Participants	51.75 years STANDARD_DEVIATION 13.18 • n=7 Participants	81 years STANDARD_DEVIATION 0 • n=5 Participants	62.4 years STANDARD_DEVIATION 12.95 • n=4 Participants	64.5 years STANDARD_DEVIATION 10.6 • n=21 Participants	67 years STANDARD_DEVIATION 0 • n=10 Participants	61 years STANDARD_DEVIATION 12.88 • n=115 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=10 Participants	10 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	4 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	12 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	12 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 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	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Region of Enrollment United States	1 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	4 participants n=4 Participants	2 participants n=21 Participants	1 participants n=10 Participants	13 participants n=115 Participants
Subset of Fugl-Meyer Upper Extremity assessment which is mainly related to the muscle synergy	25 units on a scale STANDARD_DEVIATION 0 • n=5 Participants	25 units on a scale STANDARD_DEVIATION 11.6 • n=7 Participants	8 units on a scale STANDARD_DEVIATION 0 • n=5 Participants	17.75 units on a scale STANDARD_DEVIATION 6.90 • n=4 Participants	12.5 units on a scale STANDARD_DEVIATION 2.12 • n=21 Participants	7 units on a scale STANDARD_DEVIATION 0 • n=10 Participants	18.15 units on a scale STANDARD_DEVIATION 9.47 • n=115 Participants
Onset Latency of Transcranial magnetic stimulation (TMS)-evoke motor-evoked potentials (MEP)	23.82 ms STANDARD_DEVIATION 0 • n=5 Participants	49.49 ms STANDARD_DEVIATION 20.10 • n=7 Participants	74.48 ms STANDARD_DEVIATION 0 • n=5 Participants	48.50 ms STANDARD_DEVIATION 9.81 • n=4 Participants	62.66 ms STANDARD_DEVIATION 14.86 • n=21 Participants	60.82 ms STANDARD_DEVIATION 0 • n=10 Participants	52.03 ms STANDARD_DEVIATION 16.83 • n=115 Participants
Brain symmetry index	-0.091 Index STANDARD_DEVIATION 0 • n=5 Participants	0.007 Index STANDARD_DEVIATION 0.120 • n=7 Participants	-0.091 Index STANDARD_DEVIATION 0 • n=5 Participants	0.093 Index STANDARD_DEVIATION 0.149 • n=4 Participants	0.061 Index STANDARD_DEVIATION 0.009 • n=21 Participants	-0.439 Index STANDARD_DEVIATION 0 • n=10 Participants	-0.015 Index STANDARD_DEVIATION 0.173 • n=115 Participants

PRIMARY outcome

Timeframe: The FM-UE assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intenvention) and recorded for each treatment group (anodal, cathodal, and sham). .

Population: Eight subjects completed the study were analyzed.

Outcome measures

Outcome measures
Measure	Anodal Stimulation n=8 Participants Anodal stimulation over the ipsilesional primary motor cortex	Cathodal Stimulation n=8 Participants Cathodal stimulation over the contralesional premotor cortex.	Sham n=8 Participants Sham stimulation
Fugl-Meyer Upper Extremity Assessment Part A	4.13 score on a scale Standard Deviation 4.29	5.38 score on a scale Standard Deviation 3.58	0.88 score on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: The latency of TMS-evoke MEP assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham).

Population: Eight subjects completed the study were analyzed.

This is a neurophysiological measure that determines the use of ipsilesional corticospinal tract. The paired-pulse TMS was applied at the respective hotspot for the elbow flexor muscle at the paretic arm over the ipsilesional primary motor cortex. The center of the coil was positioned tangentially to the skull. The patient was considered MEP+ if MEPs of any amplitude are observed at a consistent latency on at least 5 out 10 trials. After determining the status of MEP, at least eight more pulses were applied. We calculated average latency across all positive trials to determine the latency of MEP.

Outcome measures

Outcome measures
Measure	Anodal Stimulation n=8 Participants Anodal stimulation over the ipsilesional primary motor cortex	Cathodal Stimulation n=8 Participants Cathodal stimulation over the contralesional premotor cortex.	Sham n=8 Participants Sham stimulation
Change in Onset Latency of Transcranial Magnetic Stimulation (TMS)-Evoke Motor-evoked Potentials (MEP)	-24.21 ms Standard Deviation 9.55	-22.20 ms Standard Deviation 10.10	1.16 ms Standard Deviation 2.52

OTHER_PRE_SPECIFIED outcome

Timeframe: The BSI assessment is completed before and immediately after (within 30 min range) the intervention. The mean difference is then calculated (Post-Pre intevention) and recorded for each treatment group (anodal, cathodal, and sham).

Population: 1 missing data for anodal and sham stimulation caused by a device failure.

This is a neurophysiological measure used to quantify the symmetry or asymmetry between the left and right hemispheres of the brain. It was calculated using EEG data from a 3-minute resting state EEG recording. The scale of the index is from -1 to 1, where zero is considered perfect symmetry between hemispheres and values close to -1 and 1 indicate asymmetry.

Outcome measures

Outcome measures
Measure	Anodal Stimulation n=7 Participants Anodal stimulation over the ipsilesional primary motor cortex	Cathodal Stimulation n=8 Participants Cathodal stimulation over the contralesional premotor cortex.	Sham n=7 Participants Sham stimulation
Change in Brain Symmetry Index	0.078 score on a scale Standard Deviation 0.077	-0.068 score on a scale Standard Deviation 0.220	-0.125 score on a scale Standard Deviation 0.213

Adverse Events

Anodal Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cathodal Stimulation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

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. Yuan Yang (Principal Investigator) C/o Dr. Shirley James (Project Biostatistician)

University of Oklahoma Health Sciences Center

Phone: 4052712131

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place