Evaluation of Intensive Language Therapy

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02935842
• Date of registration: 18/08/2016
• Prospective Registration: Yes
• Primary sponsor: University Hospital, Basel, Switzerland
• Public title: Evaluation of Intensive Language Therapy EILT
• Scientific title: Effectiveness of High-frequency Specific Speech Therapy on Verbal Fluency Decline and/ or Verbal Apraxia in Patients With Parkinson's Disease With and Without Deep Brain Stimulation (DBS) - a Randomized Controlled Single-blinded Trial
• Date of first enrolment: October 1, 2016
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02935842
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Peter Fuhr, Prof.Dr.med.
• Affiliation: University Hospital, Basel, Switzerland

Key inclusion & exclusion criteria

Inclusion Criteria for all groups:

- The patient is able to cooperate

- The patient has the mental competence to provide informed consent to participate in
the study

- The patient speaks and understands German

Specific Inclusion Criteria for the DBS Group

- Fulfilling the above stated inclusion criteria as stated in a, b and c above

- The patient is responsive to Levodopa (L-DOPA)

- Having received or being scheduled for DBS

Exclusion Criteria:

- Severe psychiatric disease difficult to treat (compulsive disorder, depression, mania,
psychosis, anxiety as outlined in International Classification of Diseases (ICD-10)
(WHO 2015, current version).

- Patient with dementia (DMS-V, Mini-Mental-Status-Test (MMS) <24, Montreal Cognitive
Assessment (MoCa) <21)

- Secondary Parkinsonism

- Age =18 years

- Pregnancy (early onset)

- Presence of a known disease other than PD that shortens the life expectancy

- Mental incompetence to provide informed consent to participate in the study

- Previous intracranial surgery

- Epilepsy

- Contraindications for DBS seen in MRI-scan (malignant tumour, severe microvascular
disease)

- Insufficient skills of German language for participating in neuropsychological
evaluations

- Sensory problems, severe enough to significantly interfere with neuropsychological
assessment

- Alcohol and/or drug addiction



Age minimum: 45 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Other: Specific SL-therapy

Other: Rhythmic Balance-Movement Training (rBMT)

Primary Outcome(s)

Speech Cadence [Time Frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).]

Velocity in Gait [Time Frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).]

Speech Velocity [Time Frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).]

Cadence in Gait [Time Frame: At Baseline (BL), T1 after 4 weeks (4W-directly after intervention), T2 after 6 months (6M).]

Secondary Outcome(s)

Health Status (UPDRS) [Time Frame: At Baseline and 6 Months]

Neuropsychiatric Self-rating Questionnaires [Time Frame: At 4 Weeks and 6 Months]

Neuropsychological Standardised Test Battery [Time Frame: At 4 Weeks and at 6 Months]

Secondary ID(s)

EILT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02935842