tDCS and Aphasia Therapy in the Acute Phase After Stroke

• Sponsor: University Ghent (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03297450
• Collaborator: University Hospital, Ghent (Other)
• Enrollment: 1
• Location: 1
• Arms: 3
• Actual Duration (Months): 5.9
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This study evaluates the neuromodulatory effect of combined tDCS and aphasia therapy in patients in the acute stage after stroke. Half of the participants will receive aphasia therapy and tDCS, the other half will receive aphasia therapy and sham-tDCS.

Condition or Disease	Intervention/Treatment	Phase
Aphasia Following Cerebral Infarction	Device: tDCS; Behavioral: Aphasia therapy; Device: Sham-tDCS	Phase 2

Detailed Description

Aphasia is present in about one third of all stroke patients in the acute phase. The first few months after stroke, considerable spontaneous recovery is initiated, including neuronal plasticity and reorganization processes. Language recovery in aphasic stroke patients involves reorganization of brain functions. Longitudinal fMRI studies reveal that the right hemisphere shows increased activity at different times in the recovery process, but in the long-term is correlated with poorer performance. Left re-lateralization, if possible, seems to be the most effective in restoring language function. For a large subgroup of patients, aphasia therapy is not sufficient to resolve language deficits and not all patients are capable to endure intensive aphasia therapy. Therefore, non-invasive techniques (NIBS) such as transcranial direct current stimulation (tDCS) are currently explored as an add-on treatment to improve or accelerate therapy outcomes. tDCS is a painless and safe stimulation tool that modulates cortical excitability through weak polarizing currents (1 mA - 2 mA) between two electrodes. These weak currents are thought to induce a subthreshold shift of resting membrane potentials towards depolarization or hyperpolarization. The effects of stimulation depend on the polarity of the applied current relative to the axonal orientation. It has been found that tDCS not only triggers immediate aftereffects, but also long-lasting effects that persist beyond the stimulation time, even for up to 12 months. It was suggested that long-term potentiation (LTP) and long-term depression (LTD) might be responsible for these long-term effects, however the precise physiologic mechanisms of action are not yet fully understood.

Study Design

• Study Type: Interventional
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: The Neuromodulatory Effect of Combined Transcranial Direct Current Stimulation (tDCS) With Aphasia Therapy in the Acute Phase After Ischemic Stroke
• Actual Study Start Date: Oct 2, 2017
• Actual Primary Completion Date: Mar 30, 2018
• Actual Study Completion Date: Mar 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Aphasia therapy and tDCS	Device: tDCS; C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA; Behavioral: Aphasia therapy; Based on linguistic tests, individualized aphasia therapy will be provided
Sham Comparator: Aphasia therapy and sham-tDCS	Behavioral: Aphasia therapy; Based on linguistic tests, individualized aphasia therapy will be provided; Device: Sham-tDCS; tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)
Sham Comparator: Standard of care and sham-tDCS	Device: Sham-tDCS; tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)

Outcome Measures

Primary Outcome Measures

1. Change in naming performance [baseline, 1 week, 3 months, 6 months]

   Naming performance will be assessed with the Boston Naming Test at baseline, immediately following therapy, and after 3 and 6 months

2. Change in Vital Parameters [baseline, 1 hour (each session)]

   Blood pressure and heart rate will be measured before and after each session of treatment

Secondary Outcome Measures

1. Change in tolerability (Visual analogue scale) [baseline, 1 hour (each session)]

   A Visual analogue scale will assess tolerability before and immediately after each session

2. Change in Spontaneous Speech [baseline, 1 week, 3 months, 6 months]

   A Semi-standardized interview of the AAT will assess functional communication at baseline, immediately after therapy, and at 3 and 6 months

3. Change in ERPs [baseline, 1 week, 3 months, 6 months]

   Evoked potentials will be measured at baseline, immediately after treatment and after 3 and 6 months

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosed with mild-moderate aphasia (Token Test Score between 7 and 40)

• Inclusion in the first few days after stroke (acute phase)

• Age 18 - 85 years

• Being right-handed

• Mothertongue: Dutch

• Able to undergo functional and specific linguistic testing and therapy in the acute phase following stroke

• Imaging (CT or MRI) prior to inclusion (standard of care)

• Signed Informed Consent

Exclusion Criteria:

• History of other diseases of the central nervous system, psychological disorders and (developmental) speech and or language disorders

• Serious non-linguistic, cognitive disorders (as documented in the patients' medical history and inquired in anamneses)

• Prior brain surgery

• Excessive use of alcohol or drugs

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Ghent	Ghent	East-Flanders	Belgium	9000

Sponsors and Collaborators

• University Ghent
• University Hospital, Ghent

Investigators

• Principal Investigator: Veerle De Herdt, Prof. Dr., University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Neurologie, Principal Investigator, University Ghent
• ClinicalTrials.gov Identifier: NCT03297450
• Other Study ID Numbers: EC2017/0906
• First Posted: Sep 29, 2017
• Last Update Posted: Aug 9, 2018
• Last Verified: Aug 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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.: Yes
• Additional relevant MeSH terms: Aphasia; Cerebral Infarction; Infarction

Study Results

No Results Posted as of Aug 9, 2018