Trial Outcomes & Findings for Synchronized Brain and Hand Stimulation After Stroke (NCT NCT04502290)

Results Overview

The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline to 6 weeks

Results posted on

2025-07-15

Participant Flow

We recruited 10 participants from 2020-2024.

Participant milestones

Participant milestones
Measure	Combined Non-invasive Brain and Functional Electrical Stimulation In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
Overall Study STARTED	10
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	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	Combined Non-invasive Brain and Functional Electrical Stimulation n=10 Participants In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
Age, Continuous	61 years STANDARD_DEVIATION 5 • n=10 Participants
Sex: Female, Male Female	6 Participants n=10 Participants
Sex: Female, Male Male	4 Participants n=10 Participants
Upper Limb Fugl-Meyer Score	25 score on a scale STANDARD_DEVIATION 5 • n=10 Participants

PRIMARY outcome

Timeframe: Baseline to 6 weeks

The Box and Block Test (BBT) measures unilateral gross manual dexterity and the ability to release objects. It is a quick, simple and inexpensive test. It can be used with a wide range of populations, including clients with stroke. The BBT is composed of a wooden box divided in two compartments by a partition and 150 blocks. The BBT administration consists of asking the participants to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size, within 60 seconds. The box is oriented lengthwise and placed at the client's midline, with the compartment holding the blocks oriented towards the hand being tested. Participants first perform this test with their unaffected hand in order to practice and register baseline scores. Additionally, a 15-second trial period is permitted at the beginning of each side. Before the trial, after the standardized instructions are given to participants are advised that their fingertips must cross the partition when

Outcome measures

Outcome measures
Measure	Combined Non-invasive Brain and Functional Electrical Stimulation n=10 Participants In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
Percent Change in Box and Block Test	20 percent change of number of blocks Standard Deviation 5

SECONDARY outcome

Timeframe: Baseline to 6 weeks

Surface EMG electrodes (Ag-AgCl) will be applied to the belly of the affected EDC muscle and a reference electrode will be placed at the clavicle. The motor evoked potential (MEP) data will be collected by stimulating the targets in the grid at 2000 Hz with Signal software (CED, Cambridge, UK). The raw values are measured in mili volts, but we report as a percent change compared to the pre-intervention or baseline.

Outcome measures

Outcome measures
Measure	Combined Non-invasive Brain and Functional Electrical Stimulation n=10 Participants In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
Percent Change in Motor Evoked Potential	40 percent change of motor evoked potential Standard Deviation 7

SECONDARY outcome

Timeframe: Baseline to 6 weeks

We will measure force production of the combined wrist and finger extensors (EDC) using two 34.09 kg load cells embedded in cushioned customized platforms. The height of the load cells can be altered to accommodate individual hand sizes. Participants will perform 5 trials of combined isometric wrist and finger extension movements against load cells for 10 seconds. The force data will be amplified by 5-20K and collected at 1000 Hz using Biopac amplifier and software (Biopac Systems Inc, Goleta, CA, USA). To allow for the deliberate increase to peak force as well as the tendency to drop off near the end of the 10-second interval, we will calculate the combined wrist and finger extension force output over the central 5 second segment. We will average the force across 5 trials. The raw values are measured in kilograms force, but we report as an average percent change compared to the pre-intervention or baseline.

Outcome measures

Outcome measures
Measure	Combined Non-invasive Brain and Functional Electrical Stimulation n=10 Participants In this arm of the study participants will receive repeated non-invasive brain stimulation synchronously paired with FES
Average Percent Change in Hand Force	10 percent change of force Standard Deviation 2

Adverse Events

Combined Non-invasive Brain and Functional Electrical Stimulation

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

Amit Sethi

University of Pittsburgh

Phone: 4123836619

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place