About this trial

The goal of this phase I/II clinical trial is to determine the behavioral and neural effects of 5-daily transcranial direct current stimulation on post-stroke fatigue. The three aims are:

Aim 1: Investigate the behavioral effect of 5 daily sessions of anodal tDCS over the ipsilesional M1 on PSF.

Aim 2: Investigate the neurophysiological effect of 5 daily sessions of anodal tDCS over the ipsilesional M1.

Aim 3: Determine the relationship between changes in M1 excitability, brain connectivity and changes in PSF.

Participants will receive either a real or sham stimulation for 5 consecutive days and fatigue will be assessed before, immediately after and 1-month after the intervention. Fatigue will be assessed using clinical, behavioral, and neurophysiological outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

be at least 18 years old;

have a history of unilateral stroke ≥ 3 months prior to enrollment to ensure stability;

have an average score ≥ 4 on FSS;

have some movement capability in the more affected arm (upper extremity Fugl-Meyer(FMUE) ≥ 28) to ensure they can perform the reaching task;

Disqualifiers

acute medical problems;

the presence of any contraindication to tDCS, MRI or TMS;

the presence of significant depression (score > 10 on the Patient Health Questionnaire-9);

significant pain in the upper extremities that interferes with movements; or

Trial design

Design model

Parallel

Treatments tested in this trial

Anodal transcranial direct current stimulation
Device
Anodal tDCS will be delivered for 5 consecutive days. Participants will receive 2 mA of stimulation for 20 minutes with the anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area.
Sham transcranial direct current stimulation
Device
Sham tDCS will be delivered for 5 consecutive days. Participants will receive sham stimulation for 20 minutes with the current intensity ramping down after 30 seconds of stimulation. The anodal electrode placed on the ipsilesional primary motor cortex (M1) and the cathodal electrode placed over the contralateral supraorbital area.

Treatment groups

32 Participants

are divided into 2 treatment groups

Group A: Anodal tDCS groupExperimental treatment 1 intervention

Group B: Sham tDCSSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Fatigue Severity Scale score

This is a 9 item questionnaire and each item is rated on a Likert scale 1-7. Participants will rate their responseS based on their previous week experience. A higher score suggests more fatigue.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

2

Input-output curve slope

Brain excitability will be indexed using the input-output curve slope acquired with single-pulse transcranial magnetic stimulation (TMS)protocol. A greater slope value indicates a greater brain excitability.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

Secondary outcomes

1

Borg Rating of Perceived Exertion

Participants will rate their perceived physical effort associated with a reaching task on a scale ranging from 6 to 20. A higher rating suggests higher perceived effort.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

2

Functional connectivity of the fronto-striato-thalamic network

Brain functional connectivity will be evaluated using 10-minute resting state functional MRI. A greater correlation coefficient value indicates a greater connectivity within the network.

Time frame

This outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

3

Fatigue Scale for Motor and Cognitive Function

This is a 20-item questionnaire and each item is rated on a 5-point Likert scale. The questionnaire yields one motor and one cognitive scores. A higher score indicates more fatigue.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

4

Visual Analog Scale-Fatigue

This is a 10cm single dimension scale with a higher score indicates a higher level of fatigue.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

Other outcomes

1

Functional connectivity of other established brain networks.

Using the 10-minute resting state functional MRI data acquired, the functional connectivity of other established networks, including sensorimotor network, fronto-parietal network, and default mode network will be explored.

Time frame

This outcome will be assessed at 2 time points during the study, at baseline and immediately after the intervention ( an average of 7 days from baseline).

2

Reach movement time

Movement time (measured in seconds) will be used to index reach performance with a shorter movement time indicating a better performance.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

3

Reach reaction time

Reaction time (measured in seconds) will be used to index reach planning with a shorter reaction indicating a better performance.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

4

Reach error

Error (measured in cm) will be used to index movement accuracy with a lower error indicating a better performance.

Time frame

This outcome will be assessed at 3 time points during the study, at baseline, immediately after the intervention ( an average of 7 days from baseline) and at follow-up (an average of 5 weeks from baseline)

Behavioral and Neural Correlates of Post-Stroke Fatigue

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts