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An open label single group study on the safety of integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis

An open label single group study on the safety of integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis - A safety study on integrated volitional control electrical stimulator (IVES) for amyotrophic lateral sclerosis

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000028802
Enrollment
10
Registered
2017-08-24
Start date
2017-08-24
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

amyotrophic lateral sclerosis (ALS)

Interventions

IVES is attached to the patients, assisting the voluntary movement of the fingers. Under the supervision of occupational therapist, the patients undergo rehabilitation for 9 days with IVES for 30 minu

Sponsors

Ichinomiya Nishi Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. MMT of fingers flexion and fingers extension indicates 2-3. 2. The age at registration is from 20 years to 70 years. 3. Hospitalization or outpatient visit is possible during the intervention period 4. Written consent has been obtained

Exclusion criteria

Exclusion criteria: 1. Decline in the cognitive function (MMSE 23 points or less) 2. Complication of frontal temporal lobular dementia 3. Muscle weakness due to neuromuscular disease other than ALS 4. Wearing a ventilator 5. Receiving non-invasive positive pressure ventilation therapy all day

Design outcomes

Primary

MeasureTime frame
Primary outcome is the occurrence of serious adverse events.

Secondary

MeasureTime frame
Secondary outcomes were manual muscle test, range of motion(ROM), grip strength, pinching strength, muscle strength with hand held dynamometer, Fugl-Meyer assessment, Wolf Motor Function Test, Motor Activity Log 14, Barthel index, Visual analogue scale, Borg scale.

Countries

Japan

Contacts

Public ContactMasahiro Kanai

Ichinomiya Nishi Hospital Neurology

masabilliard35@yahoo.co.jp0586-48-0077

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026