Primary Progressive Aphasia (G31.0) G31.0
Conditions
Interventions
Group 1: Duration of 4 weeks: Speech training + rTMS [1 ½-2 hours a day/ 5 days a week]
rTMS product: MagStimRapid² by Magstim (manufacturer)
Sponsors
Universitätsklinikum Bonn
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Written consent to participation in study - Patients who are able to follow instructions and are compliant with the frequent study visits - The patient is able to understand all verbal and written information - Clinically diagnosed PPA (mild to moderate) according to current diagnostic criteria
Exclusion criteria
Exclusion criteria: General: - Patient does not consent to this study - Patient is not able to understand the extent, meaning nor the consequences of this clinical study - Patient is unable to follow the procedure of the study Medical: - Stable use of medication against dementia (< 3 months) - Strong cognitive deficits (Mini-Mental Status Test <21) - Acute psychotic episode - Neurological disorder apart from dementia being the reason for cognitive and/or language deficits (e.g. stroke, MS, Parkinson disease) Comorbid language disorder that is not due to PPA, e.g. stroke Exclusion criteria considering use of rTMS: - Standard inclusion and exclusion criteria of rTMS-treatment in psychiatric branch: - Parts of metal in/on head (e.g. clips, implanted electrodes) - Heart pacemaker - Implanted drug pumps - Intracardiac entry - Epilepsy (also within family) - Specific heart and head operations - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Direct effect of the intervention on speech ability four weeks after the intervention (rTMS & speech training) (T3) compared with baseline (T0, T1) (Primary outcome: word naming ability & usage of recall strategies) - Direct generalization effects of the intervention: comparison of performance with new test material vs. known test material considering word recall, repeating words after trainer and spontaneous speech (Cookie Theft Picture; ANELT) after the intervention (T3) - Long-term effects of the intervention on speech ability & generalization effects eight weeks after the intervention (T4) - Natural progress and fluctuations in performance of the disorder - Adherence and feasibility: - Adherence (satisfaction with treatment, subjective rTMS side-effects, using questionnaire, number of drop-outs) - Feasibility of a bigger randomized clinical study (number of patients per quarterly period, inclusion criteria, number of patients that want to participate | — |
Secondary
| Measure | Time frame |
|---|---|
| - Change in speech ability over four weeks without an intervention (T2: control of progress 2 vs. T0, T1: Baseline), assessed using parts of Aachener Aphasia Test (repeating words after trainer, speech comprehension, word naming, written language) and additional speech tests [naming performance (nouns and verbs) during screening, verbal fluency (lexical and semantic-categorical), spontaneous speech] - Individual performance progress of speech ability during training (words named correctly during training, written word naming) - Direct effects of intervention on cognition: T3 vs. T0, T1 assessed using Trail making Test (TMT) and Digit-Span-Test - Long-term effects of intervention on cognition: T4 vs. T0, T1 assessed using Trail Making Test (TMT) and Digit-Span-Test - Change of daily functioning (CBI filled in by relatives) - External assessment of communication ability through relatives (CETI and self-created questionnaire KLIA) - Life quality (QHOQOL) - Tolerability and safety of training and stimulation (side effects rTMS, AES, SAEs) - Change of brain activity (T2 vs. T3) at stimulation site and posterior language areas | — |
Countries
Germany
Contacts
Public ContactBettina Bewernick
Klinik für Neurodegenerative Erkrankungen und Gerontopsychiatrie (NEG) Universitätsklinikum Bonn
Outcome results
None listed