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TerminatedNCT03297450Updated Sep 19, 2024

TDCS and Aphasia Therapy in the Acute Phase After Stroke

An interventional study of tDCS and Aphasia therapy in Aphasia Following Cerebral Infarction, sponsored by University Hospital, Ghent. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Treatment

Why this study was terminated
Difficult patient recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
1
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Aphasia Following Cerebral Infarction
03

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1 participant (actual)

Study arms

  • Active comparator
    Aphasia therapy and tDCS

    Device: tDCS · Behavioral: Aphasia therapy

  • Sham comparator
    Aphasia therapy and sham-tDCS

    Behavioral: Aphasia therapy · Device: Sham-tDCS

  • Sham comparator
    Standard of care and sham-tDCS

    Device: Sham-tDCS

Interventions

  • DevicetDCS

    C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA

  • BehavioralAphasia therapy

    Based on linguistic tests, individualized aphasia therapy will be provided

  • DeviceSham-tDCS

    tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)

05

What researchers measure

Primary outcomes

  1. Change in naming performance

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

    Time frame: baseline, 1 week, 3 months, 6 months

  2. Change in Vital Parameters

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

    Time frame: baseline, 1 hour (each session)

Secondary outcomes

  1. Change in tolerability (Visual analogue scale)

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

    Time frame: baseline, 1 hour (each session)

  2. Change in Spontaneous Speech

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

    Time frame: baseline, 1 week, 3 months, 6 months

  3. Change in ERPs

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

    Time frame: baseline, 1 week, 3 months, 6 months

06

Study locations

1 site
  • University Hospital Ghent
    Ghent, East-Flanders 9000, Belgium
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03297450
Lead sponsor
University Hospital, Ghent
Responsible party
Sponsor
First posted
Sep 29, 2017
Start date
Oct 2, 2017
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018
Last update
Sep 19, 2024

Study contacts

Veerle De Herdt, Prof. Dr.
principal investigator · University Ghent

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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