Combining tDCS and CILT in Non-fluent Aphasia

Sponsor
University of Minnesota (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05561400
Collaborator
(none)
3
1
2
18.2
0.2

Study Details

Study Description

Brief Summary

To determine the effect of combining constraint-induced language therapy (CILT) with cerebellar tDCS in individuals with non-fluent aphasia after stroke.

The primary aims are to 1) determine the effect of combining cerebellar tDCS with constraint-induced language therapy (CILT) on language as measured by a verbal fluency task and discourse analysis task in a prospective, crossover study of adults with non-fluent aphasia after a cortical stroke and 2) demonstrate feasibility and data collection to inform a larger study.

The secondary aims include impact of the combined intervention on 1) resting state spectral EEG as measured through delta wave percentage 2) working memory as measured by the score on the Wisconsin Card Sorting Test and 3) quality of life as measured by the Stroke-Specific Quality of Life survey tool. A final secondary aim will be to identify the tolerance of the intervention and barriers to participation measured by the adverse events questionnaire.

Condition or Disease Intervention/Treatment Phase
  • Device: tDCS
  • Other: Placebo
N/A

Detailed Description

There will be two intervention conditions in this study 1) cathodal tDCS (2mA) to the right cerebellum and 2) sham tDCS to the right cerebellum. The participants will receive 20 minutes of tDCS (sham or real) during constraint-induced language therapy (CILT) followed by an additional 20 minutes of CILT alone. Two 5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder (Ferrucci et al., 2015; Sebastian et al., 2020). The electrode placement will be the same across both conditions. The CILT behavioral intervention will be led by a certified, licensed speech-language pathologist and a graduate student assistant and will follow the guidelines of CILT (Maher et al., 2006; Mozeiko et al., 2016; Pulvermuller et al., 2001). All participants will experience both intervention conditions through a cross over design. Each condition will be administered across two weeks (6 days of each condition) with a 4-week washout period between conditions. A procedural fidelity study has been completed resulting in the Standard Operating Procedures for this study. Outcome measures will be collected at the initial baseline and the first intervention phase and again after the washout period and following the second intervention phase.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
3 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Sham controlled blinded crossover designSham controlled blinded crossover design
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Combining Cerebellar tDCS and Constraint-induced Language Therapy in Non-fluent Aphasia: a Novel Approach to Target Discourse
Anticipated Study Start Date :
Jan 25, 2023
Anticipated Primary Completion Date :
Apr 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Real tDCS

the participant receives real tDCS to the right cerebellum during behavioral intervention (CILT)

Device: tDCS
5x5 saline-soaked sponge electrodes will be used with the cathode placed over the right cerebellar hemisphere; 1cm under and 4cm lateral of the inion targeting lobule VII and the anode will be placed on the right shoulder. The electrode placement will be the same across both conditions.

Placebo Comparator: Sham tDCS

the participant receives sham tDCS to the right cerebellum during behavioral intervention (CILT)

Other: Placebo
sham tDCS to the right cerebellum

Outcome Measures

Primary Outcome Measures

  1. Discourse Analysis: Picture Description [Initial Assessment/Baseline: Visit 2]

    Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance

  2. Discourse Analysis: Picture Description [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance

  3. Discourse Analysis: Picture Description [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance

  4. Discourse Analysis: Picture Description [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Picture Description using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Broken Window" picture sequence, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 24. The higher the score, the better the performance

  5. Discourse Analysis: Story Retell [Initial Assessment/Baseline: Visit 2]

    Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance

  6. Discourse Analysis: Story Retell [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance

  7. Discourse Analysis: Story Retell [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance

  8. Discourse Analysis: Story Retell [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Story Retell using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses to the "Cinderella" story retell task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 90. The higher the score, the better the performance

  9. Discourse Analysis: Procedural [Initial Assessment/Baseline: Visit 2]

    Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance

  10. Discourse Analysis: Procedural [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance

  11. Discourse Analysis: Procedural [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance

  12. Discourse Analysis: Procedural [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Procedural Discourse using Main Concept Analysis (MCA), counts of the number of main ideas or propositions that are necessary for successful discourse. Responses "how to make a peanut butter sandwich" task, a normed and standardized task will be recorded using the standardized "counts" or "raw score" main concept analysis scoring system. The maximum score is 27. The higher the score, the better the performance

  13. Verbal fluency: Semantic [Initial Assessment/Baseline: Visit 2]

    Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  14. Verbal fluency: Semantic [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  15. Verbal fluency: Semantic [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  16. Verbal fluency: Semantic [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Participant will name as many animals or foods they can in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  17. Verbal fluency: Phonemic [Initial Assessment/Baseline: Visit 2]

    Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  18. Verbal fluency: Phonemic [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  19. Verbal fluency: Phonemic [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

  20. Verbal fluency: Phonemic [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Participant will name as many words they can that start with either /f/ or /p/ in one minute. Score is scaled and reported as a raw score. The higher the score, the better. A score considered "no concerns" is >17

Secondary Outcome Measures

  1. Working Memory [Initial Assessment/Baseline: Visit 2]

    Participant will complete the Wisconsin Card Sorting Test. The score represents the raw score, total items minus errors. Maximum score is 64. The higher the score the better

  2. Working Memory [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Participant will complete the Wisconsin Card Sorting Test. The score represents the raw score, total items minus errors. Maximum score is 64. The higher the score the better

  3. Working Memory [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Participant will complete the Wisconsin Card Sorting Test. The score represents the raw score, total items minus errors. Maximum score is 64. The higher the score the better

  4. Working Memory [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Participant will complete the Wisconsin Card Sorting Test. The score represents the raw score, total items minus errors. Maximum score is 64. The higher the score the better

  5. EEG: Delta Percentage [Initial Assessment/Baseline: Visit 2]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better

  6. EEG: Delta Percentage [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better

  7. EEG: Delta Percentage [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better

  8. EEG: Delta Percentage [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Delta percentage is calculated by dividing the number of delta bands by the total frequency bands. The lower the delta percentage, the better

  9. EEG: Peak Alpha Frequency [Initial Assessment/Baseline: Visit 2]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better

  10. EEG: Peak Alpha Frequency [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better

  11. EEG: Peak Alpha Frequency [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better

  12. EEG: Peak Alpha Frequency [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Resting state EEG will be collected using the International 10/20 electrode montage. Participant will maintain eyes open with a gaze at a black screen with a white plus sign. Alpha peak frequency is calculated by filtering out all alpha bands and documenting the highest value within all alpha bands. The higher the alpha peak, the better

  13. Stroke Aphasia Quality of Life (SA-QOL) [Initial Assessment/Baseline: Visit 2]

    Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better

  14. Stroke Aphasia Quality of Life (SA-QOL) [Follow up Assessment after first treatment phase: Visit 9: 2 weeks after initial assessment]

    Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better

  15. Stroke Aphasia Quality of Life (SA-QOL) [Second baseline: Visit 10 immediately following 4 week washout: 6 weeks after initial assessment]

    Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better

  16. Stroke Aphasia Quality of Life (SA-QOL) [Follow up Assessment after second treatment phase: Visit 17: 2 week after second baseline]

    Participant will respond to questions from this standardized, valid quality of life scale. Maximum score is 39. The higher the score, the better

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • over the age of 18 years

  • history of stroke

  • diagnosed with non-fluent aphasia.

  • be able to independently understand simple directions,

  • use some speech to communicate,

  • have access to reliable transportation (including taxi and/or other transportation services),

  • fluent in English.

Exclusion Criteria:
  • Pregnancy,

  • history of seizures,

  • any metal implants in the body (excluding dental fillings),

  • history of migraines,

  • psoriasis or eczema affecting the scalp,

  • history of a head injury such as a concussion

  • diagnosis of a mental health or neurological condition/disease.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Minnesota Duluth Minnesota United States 55812

Sponsors and Collaborators

  • University of Minnesota

Investigators

  • Principal Investigator: Sharyl A Samargia-Grivette, Ph.D., University of Minnesota

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Minnesota
ClinicalTrials.gov Identifier:
NCT05561400
Other Study ID Numbers:
  • pending
First Posted:
Sep 30, 2022
Last Update Posted:
Nov 9, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by University of Minnesota
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 9, 2022