Pilot Study fostering language skills of patients with primary progressive aphasia (PPA) using a combination of speech training and brain stimulatio

Phase 2

Conditions: Primary Progressive Aphasia (G31.0)
G31.0
Circumscribed brain atrophy

Registration Number: DRKS00025757

Lead Sponsor: niversitätsklinikum Bonn

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 6

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
- 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)<br><br>- 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)<br><br>- Long-term effects of the intervention on speech ability & generalization effects eight weeks after the intervention (T4)<br><br>- Natural progress and fluctuations in performance of the disorder <br><br>- Adherence and feasibility: <br><br> - Adherence (satisfaction with treatment, subjective rTMS side-effects, using questionnaire, number of drop-outs)<br><br> - Feasibility of a bigger randomized clinical study (number of patients per quarterly period, inclusion criteria, number of patients that want to participate

Secondary Outcome Measures